Development of Evidence-Informed Physical Activity Guidelines for Adults With Multiple Sclerosis

Archives of Physical Medicine and Rehabilitation journal homepage: www.archives-pmr.org Archives of Physical Medicine and Rehabilitation 2013;94:1829-36

SPECIAL COMMUNICATION

Development of Evidence-Informed Physical Activity Guidelines for Adults With Multiple Sclerosis Amy E. Latimer-Cheung, PhD,a Kathleen A. Martin Ginis, PhD,b Audrey L. Hicks, PhD,b Robert W. Motl, PhD,c Lara A. Pilutti, PhD,b,c Mary Duggan,d Garry Wheeler, PhD,e Ravin Persad, BASc,f Karen M. Smith, MDg,h From the aSchool of Kinesiology and Health Studies, Queen’s University, Kingston, Ontario, Canada; bDepartment of Kinesiology, McMaster University, Hamilton, Ontario, Canada; cDepartment of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL; dCanadian Society for Exercise Physiology, Ottawa, Ontario, Canada; eMS Society of CanadaeAlberta & Northwest Territories Division, Edmonton, Alberta, Canada; fFusion Fitness; gDepartment of Physical Medicine and Rehabilitation, Queen’s University, Kingston, Ontario, Canada; and hSt. Mary’s of the Lake, Providence Care, Kingston, Ontario, Canada.

Abstract Most adults with multiple sclerosis (MS) are physically inactive. Physical activity guidelines are an important tool for exercise prescription, promotion, and monitoring. This article describes the application of international standards for guideline development in the creation of evidencebased physical activity guidelines for people with MS. The development process was informed by the Appraisal of Guidelines Research and Evaluation II instrument. The evidence base for the guidelines consisted of a systematic review of research examining the effects of exercise on fitness, fatigue, mobility, and health-related quality of life among people with MS. A multidisciplinary consensus panel deliberated the evidence and generated the guidelines and a preamble. Expert and stakeholder reviews of the materials led to refinement of the wording of both components of the guidelines. The resulting guidelines state that to achieve important fitness benefits, adults with MS who have mild to moderate disability need at least 30 minutes of moderate intensity aerobic activity 2 times per week and strength training exercises for major muscle groups 2 times per week. Meeting these guidelines may also reduce fatigue, improve mobility, and enhance elements of health-related quality of life. People with MS and health professionals are encouraged to adopt these rigorously developed guidelines. Archives of Physical Medicine and Rehabilitation 2013;94:1829-36 ª 2013 by the American Congress of Rehabilitation Medicine

Physical activity guidelines provide a basis for exercise prescription, goals for programs promoting physical activity participation, and benchmarks for population-based monitoring of activity levels.1 Over the past 5 years, there have been several initiatives internationally to develop evidence-based physical activity guidelines for healthy adults and children (Canada,2 United States,3 United Kingdom,4 World Health Organization5). In all cases, the newly developed guidelines are based on evidence from the general population of people without a physical Presented in a Cafe´ Scientific and as a poster at the National Meeting of the Canadian Society of Exercise Physiology (Regina, Saskatchewan, Canada, October 2012; Toronto, Ontario, Canada, October 2013). A summary of the guidelines was included in the MS Society of Canada’s consumer magazine (November 2012). Supported by the Canadian Institutes of Health Research (CIHR), an Ontario Neurotrauma Foundation Mentor-Trainee Award, and the CIHR Canada Research Chair program. No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.

disability.3,5,6 In fact, the presence of a disability is typically an exclusion criterion in the studies upon which the guidelines are based. Thus, physical activity guidelines for the general population likely are not optimal recommendations for people with a physical disability. For example, the current Canadian guidelines for adults emphasize participation in at least 150 minutes of moderate to heavy intensity physical activity each week.3-6 Inactivity and deconditioning are prevalent among people with a disability.7-9 Therefore, in certain disability groups, improvements in fitness and well-being can result from activities performed at a lower intensity and for a shorter duration than recommended in the guidelines for the general population.8,10,11 The current article reports the process undertaken to develop physical activity guidelines for adults with multiple sclerosis (MS). This process paralleled the international standards used to develop physical activity guidelines for the general population.

0003-9993/13/$36 - see front matter ª 2013 by the American Congress of Rehabilitation Medicine http://dx.doi.org/10.1016/j.apmr.2013.05.015

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Why Multiple Sclerosis?

Overview

More than 2.5 million individuals worldwide are currently living with MS and its debilitating symptoms including muscle weakness, extreme fatigue, loss of balance, impaired speech, double vision, declining cognitive function, and paralysis.12 These symptoms are associated with reduced quality of life13-15 and high health care costs (approximately $1.7 billion annually).16 Physical activity has been proposed to counteract the disabling symptoms of MS.17-19 Unfortunately, despite the benefits of physical activity, most people with MS are physically inactive.9,20-22 Up to 78% of people with MS engage in no physical activity whatsoever.20,21 This is in stark contrast to the general population of whom 38% are inactive.23 In the MS population, low levels of activity are not necessarily due to a lack of interest in being active. Physical activity advice was the most desired service in a survey of health care preferences in 471 people with MS.24 Many service providers are acutely aware of the need to promote physical activity in the MS population. However, it is very difficult to encourage and promote physical activity to people with MS if we cannot provide them with evidence-based information on the appropriate dose of activity to perform. Knowing the minimal dose (frequency, intensity, type, and duration) of physical activity for improving fitness and well-being has the potential to substantially enhance the impact and safety of existing physical activity programs and to encourage the development of new physical activity initiatives for this underserved population. This might further result in a standardized exercise prescription in clinical trials of disease-modifying benefits of exercise training. Currently, 2 research groups have put forth MS-specific physical activity recommendations.25,26 Dalgas et al25 recommend 10 to 40 minutes of moderate intensity aerobic activity 2 to 3d/wk and moderate intensity (ie, 1e4 sets of 8e15 repetitions) resistance training 2 to 3d/wk. The American College of Sports Medicine26 recommends 30 minutes of moderate intensity aerobic activity 3d/wk. Strength training is suggested; however, no indication of intensity and frequency is provided. Both these guidelines are evidence based but are not underpinned by the robust, standardized consensus guideline development process that has been advocated by professional health organizations.27 Moreover, the guidelines are based on narrative reviews of physical fitness outcomes only and do not consider other outcomes that may be key to persons with MS (eg, fatigue, mobility, and health-related quality of life [HRQOL]) and potentially influenced by physical activity. Furthermore, the quality of the evidence used to develop the recommendations was not evaluated systematically or by a consensus panel; these are key steps in a rigorous guideline development process.27,28 To meet the needs of adults with MS and their health care providers and to address methodological limitations of existing guidelines, we undertook a systematic process to develop physical activity guidelines for adults with MS.

The project was directed by 2 researchers (A.E.L.C. and K.A.M.G.) with expertise in developing physical activity guidelines for adults with mobility impairment in collaboration with: (1) a guideline development expert; (2) an Appraisal of Guidelines Research and Evaluation II (AGREE II) consultant; and (3) 3 researchers with expertise specifically related to exercise and MS (A.L.H., L.P., and R.W.M.). Stakeholders (ie, consumers, health care professionals, and service providers) were involved in formulating the guidelines and providing feedback on the guidelines. The guideline development process was guided by the AGREE II instrument27 and was consistent with the steps for physical activity guideline development outlined by Tremblay and Haskel.28 The AGREE II instrument includes 23 specific items representing 6 quality domains of a clinical practice guideline: (a) scope and purpose, (b) stakeholder involvement, (c) rigor of development, (d) clarity of presentation, (e) applicability, and (f) editorial independence.27 The specific guideline development steps included (a) determining the scope and purpose of the guideline, (b) conducting a systematic review of relevant literature,29 (c) hosting a consensus meeting to formulate the guidelines, (d) disseminating the guidelines for stakeholder feedback, and (e) having an AGREE II consultant review the guidelines and supporting materials for concordance with the AGREE II quality domains. Stakeholders were actively involved in steps (c) and (d). The guideline development process was funded by a grant from the Canadian Institutes of Health Research and the Public Health Agency of Canada. Neither funder was involved in the development of the guidelines and thus had no influence on the content of the guidelines. The next section outlines each guideline development step. Of note, the systematic review step is presented as an overview only. The full systematic review is presented in a separate, accompanying article published in this issue.29

List of abbreviations: AGREE II CSEP HRQOL MS

Appraisal of Guidelines Research and Evaluation II Canadian Society for Exercise Physiology health-related quality of life multiple sclerosis

Methods The scope and purpose The objectives, clinical questions, target population, and target users for the guidelines were determined by the project team (A.E.L.C., K.M.G., A.L.H., L.P., and R.W.M.). The consensus panel (see supplemental table 1, available online only at http:// www.archives-pmr.org/) confirmed that the objectives, clinical questions, and target populations were appropriate.
Overall objective of the guidelines: To recommend the minimum dose of physical activity necessary to improve fitness, mobility, fatigue, and HRQOL among adults with MS.
Clinical question addressed by the guidelines: What is the minimum frequency, intensity, duration, and type of training needed to generate fitness, mobility, fatigue, and HRQOL improvements among adults with MS? The guidelines are meant to generalize to all contexts including gym, clinic, and home settings. However, given that the evidence base is composed of majority structured exercise trials and all activity is performed above and beyond activities of daily living, the guidelines are especially relevant to supervised gym and clinical settings.
Population the guidelines are targeting: Adults (aged 18e64y) with mild to moderate disability (Expanded Disability Status Scale score, 0e7) resulting from relapsing-remitting and www.archives-pmr.org

Physical activity guidelines and multiple sclerosis progressive (secondary and primary progressive) forms of MS. The guidelines may be appropriate for individuals with comorbid conditions; however, these individuals are encouraged to consult a health professional prior to beginning an exercise program.
Potential users of the guidelines: (a) people living with MS as well as their families; (b) health care professionals including certified exercise physiologists, kinesiologists, trainers, physiotherapists, occupational therapists, physicians, and attendant care providers; and (c) service organizations including the Canadian Society for Exercise Physiology (CSEP) and the MS Society of Canada.

Systematic review A systematic review of research examining the effects of exercise interventions on fitness, mobility, fatigue, and HRQOL outcomes served as the evidence base to inform the guidelines. A full description of the review is provided elsewhere.29 In brief, studies were identified through a search of 7 online bibliographic databases and a hand search of relevant reviews and the personal libraries of the project team. Studies with randomized or nonrandomized controlled designs examining the effects of an exercise intervention on 1 or more outcomes of interest (fitness, mobility, fatigue, and HRQOL) among people living with MS were included in the review. No study inclusion criteria were set for participant age, type of MS, severity of disability resulting from MS, or presence of comorbid conditions. All types of comparison groups were considered including no intervention controls, standard care, and alternative exercise formats. Study quality and level of evidence were assessed using accepted evaluation measures in rehabilitation research; the quality of each study was determined using the Physiotherapy Evidence Database30 score for randomized controlled trials and the modified Downs and Black scale31 for nonrandomized controlled trials. In turn, the level of evidence each study provides was determined using a standard, 5-level system32 that distinguishes between studies of differing quality according to a study’s PEDro score or Downs and Black’s score (eg, level 1, randomized controlled trials of good to excellent quality with evidence [PEDro score>6]; level 5, n of 1 case reports).

Consensus meeting A consensus panel was convened for a 1-day meeting in November 2011 to (a) review the quality and level of evidence available to inform the guidelines and (b) formulate the guidelines. The meeting was chaired by a researcher with extensive expertise in the AGREE II process. Panel members included 5 researchers with content area expertise and experience developing physical activity guidelines and 4 stakeholders representing several health care professional groups and service organizations. The meeting was observed by an AGREE II consultant and 2 graduate-level research assistants. In advance of the meeting, panel members received tables summarizing the evidence. To start the meeting, the Chair provided an overview of the guideline development process and asked panel members to declare any conflicts of interest related to financial, professional, and other interests. No conflicts of interest were declared. Next, the consensus panel members who conducted the systematic review presented their findings one outcome at a time. Following each presentation, consensus panel members discussed whether there was adequate quality evidence to determine the minimum dose of exercise needed to produce a given outcome. www.archives-pmr.org

1831 To assist in formulating the guidelines, consensus panel members were provided a draft recommendation as a starting point. This draft recommendation was constructed by the lead author. The recommended dose of strength and aerobic training were virtually identical to the extant evidence-based recommendation put forth by Dalgas et al.33 The recommendation made by Dalgas33 was an appropriate starting point because the evidence base in that review was similar to the fitness-related evidence base for our review, with the qualification that Dalgas33 did not evaluate the quality of evidence when formulating the guidelines. The evidence was then discussed until the panel achieved unanimous consensus on the recommendations. Once the guidelines were established, the group developed a preamble to be consistent with how physical activity guidelines are presented to the general population (fig 1).34 The preamble clarifies the scope and utility of the guidelines for stakeholders. Developing the preamble required the panel to address the potential health benefits and risks associated with the guidelines. During the consensus meeting, the panel agreed that the guidelines should be reviewed and updated every 5 years at a minimum. When updating the guidelines, the consensus panel recommended considering the quality and quantity of evidence available for developing guidelines for subgroups of adults with different types of MS. However, because only the initial guidelines development process has currently been funded, the feasibility of ongoing updates is uncertain at this time. The consensus panel also discussed barriers and facilitators to implementing the guidelines. This discussion did not influence the content of the guidelines per se. However, it did provide direction for disseminating the guidelines once they were developed. Following the consensus meeting, the panel reviewed the guidelines and the preamble on 6 occasions: (a) once after the data tables for the systematic reviews were finalized (online consultation May 2012), (b) twice following expert review of the guidelines (a 1-h teleconference and online consultation June 2012), (c) twice following stakeholder review of the guidelines (a 1-h teleconference and online consultation July 2012), and (d) once following the receipt of the AGREE II review report (online consultation August 2012). These reviews resulted in minor word changes in the preamble and supporting information in the guideline (eg, how often, how to) primarily. The recommended dose of physical activity decided upon during the consensus meeting remained unchanged.

Stakeholder involvement Stakeholders had a critical role in developing and refining the guidelines. Four stakeholders representing a variety of interest groups (qualified exercise professionals [ie, CSEP Certified Exercise Physiologists and CSEP Certified Personal Trainers], physicians, and service providers) participated in the guideline development process. A panel of experts reviewed the guidelines, the preamble, and the evidence base and judged whether the guidelines and the preamble aligned with the evidence. The panel included 3 physicians whose practices were largely made up of adults with MS, 1 researcher with expertise in guideline development, and 1 researcher with expertise in exercise prescription for people with MS (see supplemental table 2, available online only at http://www.archives-pmr.org/). The panel rated on a 7-point Likert scale whether (a) the guidelines are consistent with the evidence included in the systematic review, (b) the preamble is consistent with the evidence included in the systematic review, and (c) the

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Fig 1 The guideline preamble. SOURCE. Canadian Physical Activity Guidelines for Adults With Multiple Sclerosis, ª2012. Used with permission from the Canadian Society for Exercise Physiology, www.csep.ca/guidelines.

guidelines are appropriate for adults with MS. The panel also provided suggestions for improving the guidelines and the preamble (see supplemental table 3, available online only at http:// www.archives-pmr.org/). Recognizing that consumers and policymakers were not involved in the development process, the guidelines and the preamble were circulated for stakeholder feedback. One hundred and twelve adults with MS, 125 health professionals, and 28 other stakeholders (eg, staff from the MS Society of Canada, partners of adults with MS) from across Canada reviewed the guidelines (see supplemental table 4, available online only at http://www.archivespmr.org/). Consumers with MS had varying levels of disability resulting from MS and varying levels of physical activity participation. A majority of health professionals were qualified exercise professionals but rehabilitation staff and physicians were also included. Their expertise in working with adults with MS and specifically prescribing exercise for this population varied considerably. Respondents in the “other” group had diverse occupational expertise and variable experience working with adults with MS. These stakeholders evaluated the perceived feasibility of attaining the recommended amounts of physical activity and whether they thought the guidelines were realistic, appropriate, and useful, and reflected the amount, type, and intensity of physical activity people with MS prefer and are capable of doing. Evaluations were made on 7-point scales (see supplemental table 5, available online only at

http://www.archives-pmr.org/),10 with higher scores indicating more positive evaluations. Respondents also were invited to provide suggestions for improving the presentation of the guidelines (see supplemental table 6, available online only at http://www. archives-pmr.org/). Based on participant feedback, the draft guidelines were modified to improve clarity.

AGREE II evaluation An AGREE II expert was provided the penultimate draft of the systematic review document, the preamble and the guidelines, and this report outlining the guideline development process. These documents were reviewed and a score assigned for each AGREE II domain. The guidelines and supporting documents were revised according to feedback received (see supplemental table 7, available online only at http://www.archives-pmr.org/).

Results Systematic review A detailed description of the results of the systematic review is provided in an accompanying article published in this issue. In brief, 54 studies were included in the systematic review; www.archives-pmr.org

Physical activity guidelines and multiple sclerosis approximately half were randomized controlled trials of good quality, and the remaining trials were of low quality. Of the studies included, the number of studies reporting each outcome was as follows: physical capacity (nZ11), muscular strength (nZ18), mobility (nZ25), fatigue (nZ30), and HRQOL (nZ22). There was consistent and strong evidence that exercise performed 2 times per week at a moderate intensity increases physical capacity and muscular strength. There was insufficient evidence to definitively establish the benefits of exercise training on mobility, fatigue, and HRQOL outcomes. The evidence base reflects limitations of the existent research including measurement constraints, participant selection bias, failure to distinguish between participants with varying clinical symptoms, and a strong emphasis on supervised exercise. For the most part, the age range of participants included in the evidence base was limited to 18 to 65 years of age. Their severity of disability resulting from MS ranged from an Expanded Disability Status Scale score of 0 to 7 and included only those with progressive or relapsing-remitting forms of MS.

The preamble and the guidelines The consensus panel determined that the evidence was adequate to formulate guidelines to improve aerobic capacity and muscle strength (ie, fitness) but not to achieve mobility, fatigue, or HRQOL benefits. Thus, the resulting guidelines specify the frequency, intensity, and duration of aerobic and resistance training needed to obtain fitness benefits. The guidelines only include examples of activities demonstrated in the literature to produce fitness benefits. Whereas other types of activities likely elicit fitness benefits, these activities are beyond the scope of the available evidence and have not been included in the recommendation. With regard to other potential health benefits beyond fitness improvements, panel members agreed that there was inadequate evidence to unequivocally determine such benefits. Furthermore, because adverse events associated with exercise were seldom reported,29 the panel was unable to make an evidence-based decision regarding the risks associated with following the guidelines. However, it was noted by the consensus panel that (a) in the existing evidence, exercise does not seem to exacerbate fatigue or neurological symptoms or worsen HRQOL and (b) unsupervised exercise can be safe. Thus, statements in the preamble related to adverse events are based on expert opinion. Expert reviewers corroborated the guidelines. They indicated that the guidelines (5.30.84 out of 7) and the preamble (5.70.84 out of 7) are consistent with the evidence and that the guidelines are appropriate for adults with MS (5.750.86 out of 7). The stakeholders also evaluated the guidelines positively. On each of the evaluated dimensions, average scores were above the scale midpoint, indicating agreement that the guidelines were relevant and clear, and their presentation was appropriate. The expert and stakeholder feedback is summarized in supplemental tables S3, S5, and S6 (available online only at www.archivespmr.org). The final preamble and the guidelines are presented in figures 1 and 2, respectively.

Discussion We undertook a rigorous, systematic process, consistent with international standards, to develop evidence-based physical activity guidelines for adults with MS. The resulting guidelines state that adults with MS should engage in at least 30 minutes of moderate www.archives-pmr.org

1833 intensity aerobic activity 2 times per week and strength training of major muscle groups 2 times per week to achieve important fitness benefits. Our consensus guidelines generally align with previously developed recommendations for adults with MS. Modest discrepancies presumably reflect that our guidelines express a specific, minimal dose of activity to improve fitness, whereas other guideline developers may have been aiming to establish an optimal dose (eg, Dalgas et al33 recommended a more liberal range of activityd10e 40 minutes of moderate intensity aerobic activity 2e3d/wk). Of note, our guidelines emphasize participation in supervised exercise. This focus reflects that the available research evidence is based exclusively on this form of exercise and highlights the need for more community-based exercise trials. By comparison, the recommended dose in our guideline for adults with MS is lower in duration and intensity than the amount recommended for the general population (150 minutes of moderate to heavy intensity aerobic activity each week and strength training 2 times per week). This discrepancy is a function of differences in (a) the evidence base used to inform each set of guidelines and (b) basal fitness levels such that adults with MS are generally inactive and deconditioned, and, therefore, are likely to experience improvements in fitness from a smaller dose of exercise than do adults in the general population. It is interesting to note the differences in recommendations for adults with MS and in the recently developed guidelines for adults with spinal cord injury10dto our knowledge, the only other set of rigorously developed, evidence-based physical activity guidelines for a specific disability group. The recommended dose of physical activity for adults with MS is greater in duration, yet lower in intensity than that recommended for adults with spinal cord injury (20min of moderate to heavy aerobic activity 2 times each week and strength training 2 times per week). Variation in the recommended dose of physical activity may reflect differences in the evidence informing each specific guideline and in exercise tolerance among disability subgroups. Taken together, these differences among guidelines underscore the importance of formulating disease-specific recommendations.

Applicability The guidelines will have important consumer, practice, and policy implications. Consumers who strive to meet the guidelines have the potential to obtain important fitness benefits. Improved fitness is associated with greater physical capacity and strength to perform activities of daily living, to fulfill social roles, and, overall, to enhance quality of life.35,36 Whereas individuals meeting the guidelines will likely experience numerous benefits, they may also incur some personal costs such as the financial costs associated with fitness program membership, attendant care, and transportation. The panel identified several practical implications associated with releasing physical activity guidelines for persons with MS. First, the lack of information on how to prescribe exercise to a person with a disability can dissuade fitness providers (eg, community centers, private fitness clubs, personal trainers) from being inclusive to people with disabilities. The guidelines may result in the availability and development of more fitness programs and facilities for people with MS. Second, the guidelines represent an important step toward removing existing informational barriers that have dissuaded health care practitioners from recommending physical activity to patients with MS. Third, having evidence-based guidelines could provide a foundation for building a case for

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Fig 2 The Canadian Physical Activity Guidelines for Adults with Multiple Sclerosis SOURCE. Canadian Physical Activity Guidelines for Adults With Multiple Sclerosis, ª2012. Used with permission from the Canadian Society for Exercise Physiology, www.csep.ca/guidelines.

universal coverage of physical activity expenses for people with MS. Yet, as recognized by the panel, with these opportunities come potential challenges. For instance, resistance to change of current

practices and limited program funding could be barriers to the implementation of the guidelines in fitness settings. A lack of time during patient appointments could hinder the discussion of physical

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Physical activity guidelines and multiple sclerosis activity by caregivers. Insurance providers will certainly want supporting evidence of the guidelines’ effectiveness before making decisions about physical activity coverage, and it will be important to ensure that such information is not used to scale back insurance plans that provide coverage for more than the recommended amount of physical activity.

Dissemination and implementation The guidelines have been released in partnership with the CSEP, the MS Society of Canada, and ParticipACTION. The MS Society of Canada serves adults with MS and their families by providing programs aimed at enhancing quality of life and funds research focused on preventing and treating MS. Importantly, the MS Society of Canada was identified as a key and credible source in a study that examined the preferred sources of exercise information among adults with MS.37 ParticipACTION is a national notfor-profit organization dedicated to promoting physical activity participation for all Canadians. It is widely regarded as a reputable source for physical activity information.38 The guidelines are available on the CSEP and MS Society of Canada Web sites and were addressed in our stakeholders’ newsletters. Through these channels, the guidelines have and will continue to reach consumers and health care practitioners. Recognizing that guidelines alone are not adequate for eliciting guideline uptake, the guidelines will be disseminated with informational resources providing tips on how to reach the guidelines (MS Active Now). Active dissemination strategies including consumer-focused webinars will also be used to broaden the reach of the guidelines. The guidelines will be disseminated to the scientific community through publications in peer-reviewed scientific journals and presentations at conferences.

Surveillance To our knowledge, the physical activity patterns of adults with MS are not currently being monitored. However, the North American Committee on MS does have a registry of more than 35,000 people with MS whose disease progression is being monitored annually. A similar registry is being created in Canada. These registries already include self-reported assessments of mobility, fatigue, and HRQOL. With the addition of a brief, validated self-reported physical activity questionnaire, it would be possible to determine whether individuals are meeting the guidelines and the benefits of meeting the guidelines on mobility, fatigue, and HRQOL. Although ongoing assessment of fitness outcomes (aerobic capacity and muscular strength) within these cohorts would be ideal for establishing unequivocal support for the guidelines, the expense associated with conducting these measures in a large sample would be prohibitive. This would be an important addition, allowing the registry to not only evaluate disease management activities but also health-promoting behaviors.

Study limitations In providing a transparent description of the process used to develop physical activity guidelines for adults living with MS, many of the study limitations and the strategies for addressing these limitations have already been identified throughout the article. For example, not involving consumers and policymakers as members of the consensus panel was a limitation of the process. www.archives-pmr.org

1835 However, this limitation was addressed by including representation from these groups in the later stakeholder feedback phase. The process of developing guidelines through thorough review and critical discussion of the extant research evidence made readily apparent the limitations of this research and directions for future research. Because the guidelines are a direct representation of the extant research, it is important to consider these limitations. These include the following:
Expanding the scope of outcomes assessed: research needs to examine additional meaningful outcomes including pain, depression, stress/anxiety, cognition, health outcomes, neuroprotection, and neuroregeneration.
Broadening the type of exercise intervention evaluated: The types of exercise that have been evaluated are relatively limited. A wider range of activities should be evaluated including treadmill walking, combined upper and lower body strength training, and sport, as well as cotherapeutic interventions that evaluate the additive effects of exercise and pharmacotherapy. Interventions such as a community-based ambulation program carried out in a variety of contexts also warrant further investigation. Trials evaluating flexibility and balance are needed to address stakeholders’ frequent requests for guidelines addressing these MS-relevant outcomes.
Conducting large, multicenter trials: Many of the published trials are relatively small with only 5 to 20 people receiving the exercise intervention. As a result, these trials are statistically underpowered and promising intervention effects do not reach standard levels of statistical significance. A multicenter trial would facilitate participant recruitment, allowing for adequately powered investigations.
Systematically reporting participant baseline characteristics: Several factors that may confound intervention effects (eg, baseline physical activity, receipt of disease-modifying treatments/medications, and change in mobility aid) are not reported or accounted for in existing research. More rigorous reporting would address this concern and help to identify factors that might modify intervention effects.
Using common, relevant metrics: Measurement tools and protocols vary widely from study to study, and it is difficult to compare findings across trials. Also, many of the measures used are generic and consequently not sensitive to disease-specific change. Researchers must work toward identifying and using a common set of metrics in their physical activity trials.
Expanding the target population: The research informing the current guidelines includes adults with mild to moderate disability (Expanded Disability Status Scale score ranging from 0 to 8) and fails to distinguish between adults with different types of MS. The benefits of exercise for adults with severe disability and specific types of MS have not been examined.
Monitoring contraindications to exercise: Few studies report reasons for intervention dropout, making it difficult to determine whether exercise is contraindicated for some individuals or in some stages of MS, and whether exercise is associated with disease relapse.

Conclusions This article provides an overview of the process undertaken to develop evidence-informed physical activity guidelines for adults with MS. The guidelines were developed through a rigorous multistep process

1836 aligned with international standards for developing clinical practice guidelines and physical activity guidelines specifically. These guidelines address a significant gap in informational resources available for consumers with MS as well as health care professionals, and provide a foundation for program and policy development.

Keywords Exercise; Guideline; Multiple sclerosis; Physical activity; Physical fitness; Rehabilitation

Corresponding author Amy E. Latimer-Cheung, PhD, School of Kinesiology and Health Studies, Queen’s University, 28 Division St, Kingston, Ontario, Canada K7L 3N6. E-mail address: [email protected].

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A.E. Latimer-Cheung et al 17. Motl RW. Physical activity and irreversible disability in multiple sclerosis. Exerc Sport Sci Rev 2010;38:186-91. 18. Motl RW, Arnett PA, Smith MM, Barwick FH, Ahlstrom B, Stover EJ. Worsening of symptoms is associated with lower physical activity levels in individuals with multiple sclerosis. Mult Scler 2008;14:140-2. 19. Motl RW, Weikert M, Suh Y, Dlugonski D. Symptom cluster and physical activity in relapsing-remitting multiple sclerosis. Res Nurs Health 2010;33:398-412. 20. Marrie R, Horwitz R, Cutter G, Tyry T, Campagnolo D, Vollmer T. High frequency of adverse health behaviors in multiple sclerosis. Mult Scler 2009;15:105-13. 21. Beckerman H, de Groot V, Scholten MA, Kempen JCE, Lankhorst GJ. Physical activity behavior of people with multiple sclerosis: understanding how they can become more physically active. Phys Ther 2010;90:1001-13. 22. Stuifbergen AK, Roberts GJ. Health promotion practices of women with multiple sclerosis. Arch Phys Med Rehabil 1997;78:S3-9. 23. Craig CL, Cameron C. Increasing physical activity: assessing trends from 1998-2003. Ottawa, ON, Canada: Canadian Fitness and Lifestyle Research Institute; 2004. 24. Somerset M, Campbell R, Sharp DJ, Peters TJ. What do people with MS want and expect from health-care services? Health Expect 2001;4:29-37. 25. Dalgas U, Ingemann-Hansen T, Stenager E. Physical exercise and MS recommendations. Int MS J 2009;16:5-11. 26. American College of Sports Medicine. ACSM’s resources for clinical exercise physiology: musculosketal, neuromuscular, neoplastic, immunologic, and hematologic conditions. 2nd ed. Baltimore: Wolters Kluwer; 2010. 27. Brouwers MC, Kho ME, Browman GP, et al. Development of the AGREE II, part 1: performance, usefulness and areas for improvement. CMAJ 2010;182:1045-52. 28. Tremblay MS, Haskell WL. From science to physical activity guidelines. In: Bouchard C, Blair SN, Haskell WL, editors. Physical activity and health. 2nd Edition. Champaign: Human Kinetics Publishers; 2012. p 359-80. 29. Latimer-Cheung AE, Pilutti LA, Hicks AL, et al. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review. Arch Phys Med Rehabil 2013;94:1800-28. 30. Verhagen AP, de Vet HC, de Bie RA, et al. The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus. J Clin Epidemiol 1998;51:1235-41. 31. Downs SH, Black N. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and nonrandomised studies of health care interventions. J Epidemiol Community Health 1998;52:377-84. 32. The Spinal Cord Injury Rehabilitation Evidence (SCIRE) 2010. Available at: http://www.scireproject.com. Accessed May 9, 2012. 33. Dalgas U, Stenager E, Ingemann-Hansen T. Multiple sclerosis and physical exercise: recommendations for the application of resistance-, endurance- and combined training. Mult Scler 2008;14:35-53. 34. Tremblay MS, Warburton DE, Janssen I, et al. New Canadian physical activity guidelines. Appl Physiol Nutr Metab 2011;36:36-46. 35. Kjolhede T, Vissing K, Dalgas U. Multiple sclerosis and progressive resistance training: a systematic review. Mult Scler 2012;18:1215-8. 36. Motl RW, McAuley E, Snook EM, Gliottoni RC. Physical activity and quality of life in multiple sclerosis: intermediary roles of disability, fatigue, mood, pain, self-efficacy and social support. Psychol Health Med 2009;14:111-24. 37. Sweet SN, Perrier MJ, Podzyhun C, Latimer-Cheung AE. Identifying physical activity information needs and preferred methods of delivery of people with multiple sclerosis. Disabil Rehabil. http://dx.doi.org/10. 3109/09638288.2013.800915. 38. Latimer-Cheung AE, Murumets K, Faulkner G. ParticipACTION: the national voice of physical activity and sport participation in Canada. In: Marcus B, editor. The American National Physical Activity Plan. Champaign: Human Kinetics; in press.

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Physical activity guidelines and multiple sclerosis Supplemental Table S1

1836.e1

Consensus panel

Name

Expertise and Institution

Role(s)

Amy Latimer-Cheung

Knowledge Synthesis, Guideline Development, Content (disability, practice), Knowledge Translation: Queen’s University Knowledge Synthesis, Guideline Development, Content (disability, practice), Knowledge Translation: McMaster University Knowledge Synthesis, Guideline Development and Dissemination: Canadian Society for Exercise Physiology Guideline Development, Content (MS, disability, practice): Independent business owner Knowledge Synthesis, Guideline Development, Knowledge Translation: McMaster University Knowledge Synthesis, Guideline Development, Content (MS, disability, practice): McMaster University Knowledge Synthesis, Content (MS, disability): University of Illinois at Urbana Champaign Guideline Development, Content (MS, disability, clinical practice): Queen’s University, Providence Care Content (MS, clinical practice): MS Get Fit Toolkit

Leadership, Project Direction

Kathleen Martin Ginis Mary Duggan

Ravin Persad Melissa Brouwers (PhD) Audrey Hicks (PhD) Robert Motl (PhD) Karen Smith (MD) Garry Wheeler (PhD) Lara Pilutti (PhD)

Content (MS, disability) University of Illinois at Urbana Champaign

Leadership, Project Direction

Stakeholder, Guideline Dissemination

Stakeholder Overall Process Advisor Content ExpertdPhysiology Content ExpertdWell-being, Physiology Content ExpertdClinical Stakeholder, Content ExpertdWell-being, Physiology Content ExpertdPhysiology

NOTE. Author names and institutions removed for blind review.

Supplemental Table S2

Expert review panel

Name

Credentials

Mark Tremblay, PhD

Research expertise: Obesity prevention ChairdPhysical Activity Guidelines Development, CSEP Director of Healthy Active Living and Obesity Research Children’s Hospital of Eastern Ontario Specialty: Physical Medicine and Rehabilitation Staff Physician and Director of Electromyography Toronto Rehabilitation Institute Specialty Neurology Staff Physician Kingston General Hospital Research expertise: Exercise physiology in special populations Professor of Occupational Therapy Faculty of Rehabilitation Medicine University of Alberta Specialty: Physical Medicine and Rehabilitation Senior Resident University of British Columbia GF Strong Rehabilitation Centre Clinical Research trainee, Harvard Medical School

Tania Bruno, MD

Donald Brunet, MD

Yagesh Bhambhani, PhD

Kim Waspe, MD

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1836.e2 Supplemental Table S3

A.E. Latimer-Cheung et al Guideline evaluation and feedback from expert panel

Expert Comment Guidelines The emphasis on the “AND” needs to be reconsidered. The evidence suggests fitness benefits from aerobic and resistance either separately or in combination.

Add A section on how to monitor progress Elliptical trainers as a mode of exercise to reach the guideline

Clarify Activity intensities using heart rate parameters, the number of repetitions maximum, and Borg’s Scale for ratings of perceived exertion

The term “important fitness benefits” Is the goal to achieve 30min of continuous exercise?

Preamble Clarify the definition of minimal to moderate disability.

Statements regarding adverse events are not clearly linked to the evidence base. Clarify recommendation to progress toward the guideline. Any prescreening necessary prior to participating in exercise?

Response to Feedback The consensus panel agreed to maintain its recommendation for both aerobic and strength training activity on the basis that (a) there is evidence of the benefit of the combined programs, (b) engaging in a combined program has the potential to produce diverse fitness benefits (ie, both aerobic and strength), and (c) engaging in one type of activity may facilitate participation in the other (eg, gaining strength may allow a previously deconditioned individual to generate adequate power to perform moderate-intensity aerobic activities [eg, pedal a bicycle with moderate resistance]). All this information will be included in the accompanying physical activity guide (under development). This mode of exercise has been added in the “How to” section. It is consistent with emerging evidence that is cited in the discussion of the systematic review. To maintain clarity and consistency with other CSEP guidelines, intensity definitions were not changed. Moreover, heart rate is not a consistent indicator of intensity among people with MS with autonomic impairment. There is little evidence of the validity of the Borg Scale’s ratings of perceived exertion specifically among people with MS. Clarified in the preamble The word “continuous” was added to aerobic activity in the guideline. Please refer to Table S6 regarding further revision. In the stakeholder survey, participants were asked whether they thought Expanded Disability Status Scale (EDSS) scores should be added into the guideline statement to clarify the meaning of minimal to moderate disability. A total of 69.41% of the respondents indicated that EDSS scores should not be added to the guideline. This lack of evidence documenting injury or adverse events has been made more prominent in the systematic review. Clarified in the preamble No requirements for prescreening were added to the preamble. This approach is consistent with the preamble for other CSEP guidelines.

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Physical activity guidelines and multiple sclerosis Supplemental Table S4

1836.e3

Demographic characteristics of stakeholder survey respondents % (n)

Demographic Characteristic

Health Professionals (nZ125)

Adults With MS (nZ112)

Gender (% female) Province/territory Ontario Quebec West East Occupation Qualified exercise professional Rehabilitation (OT/PT) MD Nurse MS Society staff Researcher Social work Other Years in specialty 0e5 6e10 11e15 16e20 21e25 26þ Experience with an adult with MS Never Rarely Sometimes Frequently All of the time Frequency of prescribing exercise to someone with MS 0e10 times 11e20 times 21e30 times 31e40 times 41þ times Gender (% female) Type of MS Relapsing-remitting Primary progressive Secondary progressive Progressive-relapsing Years since diagnosis, mean  SD EDSS score, mean  SD Currently meeting PA guideline (% yes)

70.0 (77)

72.7 (16)

44.1 14.4 39.6 1.8

(49) (16) (44) (2)

60.9 4.3 20.4 4.3

(14) (1) (7) (1)

66.7 13.9 5.6 4.6

(72) (15) (6) (5)

17.6 0 0 0 35.3 5.9 17.6 23.5

(3)

6.5 (7) 2.8 (3)

Other (nZ25)

(6) (1) (3) (4)

42.3 17.1 15.3 9.9 11.7 3.6

(47) (19) (17) (11) (13) (4)

45.0 15.0 10.0 15.5 0 15.5

(9) (3) (2) (3)

13.5 43.2 11.7 16.2 15.3

(15) (48) (13) (18) (17)

21.1 21.1 0 5.3 52.6

(4) (4)

65.8 9.9 4.5 3.6 16.2

(73) (11) (5) (4) (18)

58.8 11.8 5.9 5.9 17.6

(10) (2) (1) (1) (3)

(3)

(1) (10)

76.5 (75) 51.0 (53) 24.0 (25) 20.2 (21) 4.8 (5) 15.155.42 5.422.15 48.6 (51)

NOTE. Sample sizes vary for each demographic characteristicdhealth professionals, nZ108e125; adults with MS, nZ33e105; other, nZ17e25. Abbreviations: EDSS, Expanded Disability Status Scale; MD, doctor of medicine; OT, occupational therapist; PA, physical activity; PT, physical therapist.

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1836.e4 Supplemental Table S5

A.E. Latimer-Cheung et al Stakeholder evaluations of the guidelines Health Care Practitioners

Item Perceived feasibility Is the guideline appropriate for individuals with MS who have mild to moderate disability? Is the guideline a realistic goal if the person is motivated and has all resources necessary? Reflect amount, type, and intensity of PA that people with MS/you potentially would do? How confident that your client/you can meet this guideline? Perceived utility Provide useful information for people with MS/you? Provide useful information for practitioners? Use this guideline in your practice? Presentation and clarity Provide practitioners/you clear instructions about how much PA should be done in a week? Provide practitioners/you clear instructions about the intensity level of PA? Provide practitioners/you clear instructions about how much PA should be done in 1 session? Preamble clarity The preamble is clear The preamble is comprehensive I agree with the preamble

Individuals With MS

Other

n

Mean  SD

n

Mean  SD

n

Mean  SD

125

5.561.23

110

5.261.71

28

4.961.73

125

5.911.32

112

5.541.75

27

5.071.66

125

4.901.47

112

5.061.79

27

3.851.83

125

4.951.56

111

4.912.12

27

3.811.80

125 125 125

5.351.50 5.421.52 5.531.48

110

5.291.75

27 27 25

4.441.78 4.671.66 4.482.00

121

5.971.27

110

5.811.55

27

5.041.87

125

5.581.40

110

5.571.62

27

4.891.85

125

5.511.48

109

5.581.54

27

4.891.83

117 117 116

5.971.05 5.811.17 5.831.38

25 25 25

5.001.85 4.841.80 4.801.89

NOTE. Items were rated on a 7-point scale, with higher scores indicating more positive ratings. Abbreviation: PA, physical activity.

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Physical activity guidelines and multiple sclerosis Supplemental Table S6

Stakeholder feedback

Suggestions for Improvement Guideline Feedback Clarify whether both aerobic and strength training activities can be done in 1 exercise session. Clarify intensity and dose of strength training and meaning of major muscle group.

Clarify “Other exercises that may bring benefit.”

No mention of flexibility or balance Concern regarding continuous activity

Clarify intensity definition for aerobic activity. Should doctor’s approval be required?

Need to emphasize progression in strength training Indicate that programs should be individualized. Provide more activity examples.

Address precautions that should be taken. Preamble Feedback Definition of health professional should be expanded. Referring back to “health professionals” is a circular referral if the preamble is meant for health professionals. Expand on the statement related to exercise supervision. Perhaps a definition/clarification of “activities of daily living”

Indicate that programs should be individualized.

Add special considerations that individuals with MS may have (eg, balance and coordination).

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1836.e5

Response to Feedback A statement has been added to the guideline indicating that aerobic and strength training can occur in the same exercise session. No changes were made to maintain consistency with existing guidelines for other groups. The term “major muscle group” was not expanded upon. Providing specific examples may reduce the relevance of the guidelines to individuals who do not have function in the muscle group identified. No changes were made. The evidence does not allow for a stronger statement, and the activities could not easily be placed into the aerobic or strength training categories. There is not adequate, quality evidence to make statements about flexibility or balance. The term “continuous” was deleted from the guideline. Concern was raised that requiring 30min of continuous activity might make the guideline inaccessible for some individuals. This decision is consistent with the evidence. While studies in the evidence base clearly state aerobic activity duration, it was not clearly or consistently stated that activity was continuous. No changes were made to maintain consistency with existing guidelines for other groups. The preamble was modified to include the statement “Adults with multiple sclerosis may wish to consult a health professional .” No change made. The guideline already recommends gradual increases. All this information will be included in the accompanying physical activity guide (MS Get Fit Toolkit). All this information will be included in the accompanying physical activity guide MS Society of Canada (Alberta and Northwest Territories Division). All this information will be included in the accompanying physical activity guide (MS Get Fit Toolkit). No change made to maintain consistency with other CSEP guidelines No change made. While health professionals are the target audience for the preamble, the preamble will also be used to develop supporting materials. Clarification has been added encouraging supervision when beginning an exercise program. No change made to maintain consistency with other guidelines and generalizability of the guideline to a broad group of individuals with MS who participate in some activities of daily living but not others. All this information will be included in the accompanying physical activity guide (MS Get Fit Toolkit). All this information will be included in the accompanying physical activity guide (MS Get Fit Toolkit).

1836.e6 Supplemental Table S7

A.E. Latimer-Cheung et al AGREE II evaluation and suggestions for improvement

AGREE II Domain

Score

Overall guideline quality Scope and purpose The overall objective(s) of the guideline is (are) specifically described. The health question(s) covered by the guideline is (are) specifically described.

6/7 19/21 7/7

The population (patients, public, etc) to whom the guideline is meant to apply is specifically described.

6/7

6/7

Stakeholder involvement The guideline development group includes individuals from all relevant professional groups. The views and preferences of the target population (patients, public, etc) have been sought. The target users of the guideline are clearly defined.

20/21 7/7

Rigor of development Systematic methods were used to search for evidence.

47/56 6/7

Suggestions for Improvement

Response to Feedback


Not clear what the comparison group would be for randomized controlled studies
The setting is also not clear (eg, at home? in community gym?).
Specify age range for adults
Clarify mild to moderate disability with Expanded Disability Status Scale scores
Are the guidelines relevant to adults with comorbidities?


Comparison group has been clarified in the description of the systematic review.
The guidelines are meant to generalize across settings.
An age range corresponding with the age of participants in the studies reviewed has been specified.
Stakeholders indicated that the inclusion of EDSS scores would not add clarity.
The target population for the guidelines now includes individuals with comorbidities.


The target users are not included in either the preamble or the guideline.


The target users are listed in the preamble.


The complete search strategy could have been included as an appendix.
Specify participant inclusion criteria (age, disability, comorbidities).
Identify type of comparison groups considered.


The citation for the associate systematic review is provided.


Adverse events/effects were not an explicit outcome of interest in the review.
Clarify the basis of statements regarding adverse events.
Link between recommendations and (key) evidence not explicit
Greater clarity around expert opinion used rather than evidence


Clarified in results that statements regarding adverse events are based on expert opinion.

7/7

6/7

The criteria for selecting the evidence are clearly described.

5/7

The strengths and limitations of the body of evidence are clearly described. The methods for formulating the recommendations are clearly described. The health benefits, side effects, and risks have been considered in formulating the recommendations.

6/7

There is an explicit link between the recommendations and the supporting evidence.

5/7

The guideline has been externally reviewed by experts prior to its publication.

7/7


Noted in the description of systematic review, no participant inclusion criteria applied, and types of comparison groups considered identified.

7/7

4/7


Clarified in results that guidelines are based on evidence of improved aerobic capacity and muscle strength.
Use of expert opinion has been clarified.

(continued on next page)

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Physical activity guidelines and multiple sclerosis

1836.e7

Supplemental Table S7 (continued ) AGREE II Domain

Score

A procedure for updating the guidelines is provided. Clarity of presentation The recommendations are specific and unambiguous.

7/7

The different options for the management of the condition or health issue are clearly presented. Key recommendations are easily identifiable. Applicability The guideline describes facilitators and barriers to its application.

7/7

The guideline provides advice and/or tools on how the recommendations can be put into practice. The potential resource implications of applying the recommendations have been considered. The guideline presents monitoring and/or auditing criteria. Editorial independence The views of the funding body have not influenced the content of the guideline. Competing interests of guideline development group members have been recorded and addressed.

7/7

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20/21 6/7

Suggestions for Improvement

Response to Feedback


Add specific age range and define mild to moderate disability.
The uncertainty and lack of evidence regarding the other outcomes ought to be included in either the guidelines or the preamble.


Age range has been added.
The role of expert opinion has been clarified in the preamble.


Information was not included as to how and when this information was sought and how it influenced guideline development.
No mention of criteria for assessing improvements, frequency of measurement, study design


Clarified in the “Methods” section that barriers and facilitators were discussed during the consensus meeting.
Potential outcomes have been identified and considerations for data collection have been discussed.


A statement describing the role of the funding bodies was not included.


A statement has been included.


Clarify the types of conflict of interest queried


Types of conflict of interest are listed.

7/7 23/28 5/7

6/7

5/7

12/14 6/7

6/7