- Email: [email protected]
Train High Eat Low for Osteoarthritis study (THE LO study): protocol for a randomized controlled trial
G Model
JPHYS-160; No. of Pages 1 Journal of Physiotherapy xxx (2015) xxx–xxx
Journal of
PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys
Appraisal
Trial Protocol
Train High Eat Low for Osteoarthritis study (THE LO study): protocol for a randomized controlled trial Yareni Guerrero a, Najeebullah Soomro a, Guy Wilson a, Yian Dam a, Jacinda Meiklejohn a, Kylie Simpson a, Richard Smith a, Jennie Brand-Miller b, Milena Simic c, Helen O’Connor a,b, Yorgi Mavros a, Nasim Foroughi d, Tat Poon e, Kate Bradshaw a, Lyn March f, Benedicte Vanwanseele a,g, Felix Eckstein h, Marlene Fransen c, Joao Bergamasco i, Ananthila Anandacoomarasamy e, Maria Fiatarone Singh a,j,k a Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre; b School of Molecular Bioscience and Charles Perkins Centre; c Discipline of Physiotherapy, Arthritis and Musculoskeletal Research Group, Faculty of Health Sciences, The University of Sydney, Lidcombe; d School of Medicine, University of Western Sydney (Campbelltown Campus), Campbelltown; e Department of Rheumatology, Concord Repatriation Hospital, Concord; f Northern Clinical School, Royal North Shore Hospital, The University of Sydney; g Department of Kinesiology, Faculty of Kinesiology and Rehabilitation Sciences, KU Leuven, Leuven, Belgium; h Institute of Anatomy, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; i Universidade Federal de Sa˜o Carlos, Departamento de Educac¸a˜o Fı´sica e Motricidade Humana, Sa˜o Carlos, Sa˜o Paulo, Brasil; j Sydney Medical School, The University of Sydney, Camperdown, Australia; k Hebrew SeniorLife Boston, and Jean Mayer USDA Human Nutrition Research Centre on Aging at Tufts University, Boston, USA
Abstract Introduction: Osteoarthritis (OA) is one of the most prevalent chronic conditions among older adults, with the medial tibiofemoral joint being most frequently affected. The knee adduction moment is recognized as a surrogate measure of the medial tibiofemoral compartment joint load and therefore represents a valid intervention target. This article provides the rationale and methodology for THE LO study (Train High, Eat Low for Osteoarthritis), which is a randomized controlled trial that is investigating the effects of a unique, targeted lifestyle intervention in overweight/obese adults with symptomatic medial knee OA. Research question: Compared to a control group given only lifestyle advice, do the effects of the following interventions result in significant reductions in the knee adduction moment: (1) gait retraining; and (2) combined intervention (which involves a combination of three interventions: (a) gait retraining, (b) highintensity progressive resistance training, and (c) high-protein/lowglycaemic-index energy-restricted diet)? It is hypothesized that the combined intervention group will be superior to the isolated interventions of the high-protein/low-glycaemic-index diet group and the progressive resistance training group. Finally, it is hypothesized that the combined intervention will result in a greater range of improvements in secondary outcomes, including: muscle strength, functional status, body composition, metabolic profile, and psychological wellbeing, compared to any of the isolated interventions or control group. Design: Single-blinded, randomized controlled trial adhering to the CONSORT guidelines on conduct and reporting of non-pharmacological clinical trials. Participants: One hundred and twenty-five community-dwelling people are being recruited. Inclusion criteria include: medial knee OA, low physical activity levels, no current resistance training, body mass index 25 kg/m2 and age 40 years. Intervention and control: The participants are stratified by sex and body mass index, and randomized into one of five groups: (1) gait retraining; (2) progressive resistance training; (3) high-protein/low-glycaemic-index energy-restricted diet (25 to 30% of energy from protein, 45% of energy from carbohydrates, < 30% of energy from fat, and
glycaemic index diet value < 50); (4) a combination of these three active interventions; or (5) a lifestyle-advice control group. All participants receive weekly telephone checks for health status, adverse events and optimisation of compliance. Measurements: Outcomes are measured at baseline, 6 and 12 months. The primary outcome is the peak knee adduction moment during the early stance phase of gait. The secondary outcome measures are both structural (radiological), with longitudinal reduction in medial minimal joint space width at 12 months, and clinical, including: change in body mass index; joint pain, stiffness and function; body composition; muscle strength; physical performance/ mobility; nutritional intake; habitual physical activity and sedentary behaviour; sleep quality; psychological wellbeing and quality of life. Discussion: THE LO study will provide the first direct comparison of the long-term benefits of gait retraining, progressive resistance training and a high-protein/ low-glycaemic-index energy-restricted diet, separately and in combination, on joint load, radiographic progression, symptoms, and associated co-morbidities in overweight/obese adults with OA of the knee. Trial Registration: Australia and New Zealand Clinical Trials Register. Registration Number: ACTRN12612000501842. Was this trial prospectively registered: No. Date of trial registration: 9 May 2012 (date of first enrolment 1 February 2012). Funding: This project was funded by the National Health and Medical Research Council. Funder approval number: NHMRC Grant ID 1006769. Anticipated completion date: December 2016. Provenance: Not invited. Peer-reviewed. Corresponding author: Maria A Fiatarone Singh, MD, FRACP, Exercise, Health and Performance Faculty Research Group, Faculty of Health Sciences, University of Sydney, 75 East Street, Lidcombe, NSW 2141, Australia. Email: Maria.fi[email protected] Full protocol: Available on the eAddenda at doi:10.1016/j.jphys. 2015.05.020
http://dx.doi.org/10.1016/j.jphys.2015.05.020 1836-9553/ß 2015 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.
Please cite this article in press as: Guerrero Y, et al. Train High Eat Low for Osteoarthritis study (THE LO study): protocol for a randomized controlled trial. J Physiother. (2015), http://dx.doi.org/10.1016/j.jphys.2015.05.020
JPHYS-160; No. of Pages 1 Journal of Physiotherapy xxx (2015) xxx–xxx
Journal of
PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys
Appraisal
Trial Protocol
Train High Eat Low for Osteoarthritis study (THE LO study): protocol for a randomized controlled trial Yareni Guerrero a, Najeebullah Soomro a, Guy Wilson a, Yian Dam a, Jacinda Meiklejohn a, Kylie Simpson a, Richard Smith a, Jennie Brand-Miller b, Milena Simic c, Helen O’Connor a,b, Yorgi Mavros a, Nasim Foroughi d, Tat Poon e, Kate Bradshaw a, Lyn March f, Benedicte Vanwanseele a,g, Felix Eckstein h, Marlene Fransen c, Joao Bergamasco i, Ananthila Anandacoomarasamy e, Maria Fiatarone Singh a,j,k a Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre; b School of Molecular Bioscience and Charles Perkins Centre; c Discipline of Physiotherapy, Arthritis and Musculoskeletal Research Group, Faculty of Health Sciences, The University of Sydney, Lidcombe; d School of Medicine, University of Western Sydney (Campbelltown Campus), Campbelltown; e Department of Rheumatology, Concord Repatriation Hospital, Concord; f Northern Clinical School, Royal North Shore Hospital, The University of Sydney; g Department of Kinesiology, Faculty of Kinesiology and Rehabilitation Sciences, KU Leuven, Leuven, Belgium; h Institute of Anatomy, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; i Universidade Federal de Sa˜o Carlos, Departamento de Educac¸a˜o Fı´sica e Motricidade Humana, Sa˜o Carlos, Sa˜o Paulo, Brasil; j Sydney Medical School, The University of Sydney, Camperdown, Australia; k Hebrew SeniorLife Boston, and Jean Mayer USDA Human Nutrition Research Centre on Aging at Tufts University, Boston, USA
Abstract Introduction: Osteoarthritis (OA) is one of the most prevalent chronic conditions among older adults, with the medial tibiofemoral joint being most frequently affected. The knee adduction moment is recognized as a surrogate measure of the medial tibiofemoral compartment joint load and therefore represents a valid intervention target. This article provides the rationale and methodology for THE LO study (Train High, Eat Low for Osteoarthritis), which is a randomized controlled trial that is investigating the effects of a unique, targeted lifestyle intervention in overweight/obese adults with symptomatic medial knee OA. Research question: Compared to a control group given only lifestyle advice, do the effects of the following interventions result in significant reductions in the knee adduction moment: (1) gait retraining; and (2) combined intervention (which involves a combination of three interventions: (a) gait retraining, (b) highintensity progressive resistance training, and (c) high-protein/lowglycaemic-index energy-restricted diet)? It is hypothesized that the combined intervention group will be superior to the isolated interventions of the high-protein/low-glycaemic-index diet group and the progressive resistance training group. Finally, it is hypothesized that the combined intervention will result in a greater range of improvements in secondary outcomes, including: muscle strength, functional status, body composition, metabolic profile, and psychological wellbeing, compared to any of the isolated interventions or control group. Design: Single-blinded, randomized controlled trial adhering to the CONSORT guidelines on conduct and reporting of non-pharmacological clinical trials. Participants: One hundred and twenty-five community-dwelling people are being recruited. Inclusion criteria include: medial knee OA, low physical activity levels, no current resistance training, body mass index 25 kg/m2 and age 40 years. Intervention and control: The participants are stratified by sex and body mass index, and randomized into one of five groups: (1) gait retraining; (2) progressive resistance training; (3) high-protein/low-glycaemic-index energy-restricted diet (25 to 30% of energy from protein, 45% of energy from carbohydrates, < 30% of energy from fat, and
glycaemic index diet value < 50); (4) a combination of these three active interventions; or (5) a lifestyle-advice control group. All participants receive weekly telephone checks for health status, adverse events and optimisation of compliance. Measurements: Outcomes are measured at baseline, 6 and 12 months. The primary outcome is the peak knee adduction moment during the early stance phase of gait. The secondary outcome measures are both structural (radiological), with longitudinal reduction in medial minimal joint space width at 12 months, and clinical, including: change in body mass index; joint pain, stiffness and function; body composition; muscle strength; physical performance/ mobility; nutritional intake; habitual physical activity and sedentary behaviour; sleep quality; psychological wellbeing and quality of life. Discussion: THE LO study will provide the first direct comparison of the long-term benefits of gait retraining, progressive resistance training and a high-protein/ low-glycaemic-index energy-restricted diet, separately and in combination, on joint load, radiographic progression, symptoms, and associated co-morbidities in overweight/obese adults with OA of the knee. Trial Registration: Australia and New Zealand Clinical Trials Register. Registration Number: ACTRN12612000501842. Was this trial prospectively registered: No. Date of trial registration: 9 May 2012 (date of first enrolment 1 February 2012). Funding: This project was funded by the National Health and Medical Research Council. Funder approval number: NHMRC Grant ID 1006769. Anticipated completion date: December 2016. Provenance: Not invited. Peer-reviewed. Corresponding author: Maria A Fiatarone Singh, MD, FRACP, Exercise, Health and Performance Faculty Research Group, Faculty of Health Sciences, University of Sydney, 75 East Street, Lidcombe, NSW 2141, Australia. Email: Maria.fi[email protected] Full protocol: Available on the eAddenda at doi:10.1016/j.jphys. 2015.05.020
http://dx.doi.org/10.1016/j.jphys.2015.05.020 1836-9553/ß 2015 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.
Please cite this article in press as: Guerrero Y, et al. Train High Eat Low for Osteoarthritis study (THE LO study): protocol for a randomized controlled trial. J Physiother. (2015), http://dx.doi.org/10.1016/j.jphys.2015.05.020