A controlled trial of cardiac rehabilitation in the home setting using electrocardiographic and voice transtelephonic monitoring

Secondary

Prevention

and Rehabilitation

A controlled trial of cardiac rehabilitation home setting using electrocardiographic voice transtelephonic monitoring Philip A. Ades, MD, Fred&J. Pashkow, James R. Nestor, PhD Burlington, Vt

Objective diac

The

rehobilitation

goal with

Background cardiovascular with

heart

Methods simultaneous

voice

Primary

outcome

Results who tions,

phonically

role

aerobic

exercise-related

demonstrated total overall

capacity

and

program

and

medical

MD,

monitored

quolity

in either

participation

car-

rehabilitation

The

nurse

study

peak

of physical

capacity social

similarly

in both

A total

of 3 100

hours

decrease

rates

in patients

of eligible

program was

(n = 83 were

Health

physical There

of home

with

with

were

exercise

trial.

Questionnaire.

degree

functioning, groups.

patients) controlled

Status

to a similar

patients.

compared

a multicenter,

by the

functioning,

improved group.

aerobic

at 15%

coordinator

design

capacity,

mortality

is only

of life, as measured

increased

exercise

cardiovascular

located

patients).

energy/fatigue events

R. Zohman,

transtelephonically

to increase

and

monitored

to a centrally

(n = 50

of life domains

pain,

been decrease

national

transmission program

Quality

bodily

of home-based,

transtelephonically

monitoring

vs 23%).

limitations,

major

as patients role

limita-

no circulatory were

transtele-

monitored.

Conclusions bilitation,

peak

in the home-based

on site (18%

or other

home-based,

rehabilitation were

and

factors,

L. Pina, MD, Lenore

rehabilitation. has

status,

of multiple

MD, Ileana

the effectiveness

rehabilitation

electrocardiographic on-site

Patients

emotional

arrests

2000;

and variables

exercised

Because

Fletcher,

cardiac

psychosocial

of a 3- month

of a standard

to compare supervised

in cardiac

improve

disease.

Effects

was

on-site,

Participation symptoms,

coronary

effects

of this study standard,

MD, Gerald

in the and

with

Patients

exercise

and

with quality

coronary

heort

disease

of life improvements

can

effectively

comparable

participate to those

in home-based, demonstrated

at on-site

monitored programs.

cardiac (Am

rehaHeart

J

139543-8.)

It is well-documented that supervised, on-site cardiac rehabilitation for patients with coronary heart disease results in increased exercise capacity, decreased symptoms of angina and dyspnea, improved psychosocial well-being and stress levels, and reduced rates of total and cardiovascular mortality. 1 These benefits can be delivered safely, in appropriately screened patients, with coronary death rates during rehabilitation sessions ranging from 1 death per 116,000 patient hours to 1 death per 784,000 patient hours.2,3 However, despite these well-established benefits, delivered in a safe and From the Dwrr~on of Cordmlogy, Fletcher-Allen Health Core, University of Vermont College of Medrme Supported by Roytel Medal Corporation, Wmdsor, Corm Presented m pari 01 The Amencon College of Cardiology Notional Meetmg, Dolfos, TX, March 1996. SubmItted May I I, 1999; accepted August 12, 1999. Reprmt requests: PhIlip A. Ada, MD, McClure I, Cordnlogy Medrcol Center Hospltol of Vermont, Burhngion, VT 0540 I E.mo& PhtCp.Ades@tmednet erg Copyright 0 2000 by Morby, Inc. 0002.8703/2000/8 12.00 + 0 4/I/102193

supportive environment, only 15% of eligible patients actually participate in cardiac rehabilitation pr0grams.t Reasons for nonparticipation include lack of geographically available programs, transportation or work constraints, and physician nonreferral.* The concept of home-based cardiac rehabilitation is not new. Studies from the 1980s document the feasibility of home-based rehabilitation in primarily low-risk patients with coronary artery disease.5-7More recent studies have incorporated intensive risk factor modification alongside the home exercise component.8q9 Many have advocated the expansion of home-based rehabilitation programs as a solution for the low rates of participation in cardiac rehabilitation programs.6~8~10~11 Recent technologic advances allow the use of simultaneous online transtelephonic electrocardiogram (ECG) and voice monitoring during cardiac rehabilitation exercise sessions.” In this study, exercise capacity and quality of life outcomes of home-based, transtelephonically monitored rehabilitation were compared with outcomes after on-site rehabilitation. There was no preferential selection of lower

Amerlcon

544

Ades

et al

Table

I. Baseline

characteristics

Home 83 56f9 63 M (76%) 20 F (24%) 27.6 f 4.6

N Age (~1

Sex Body mass index Diagnoses CABG MI PTCA Transplant Peak aerobic capacity (mt/kg/min) Health status questionnaire Health perception Physical functioning Role limitations-physical Role limitations-emotional Social functioning Mental health Bodily pain Energy/fatigue CABG, Coronary

Heorl Journal March 2000

artery bypass grohing; Ml, myocardial

On-site

P value

50 58f 12 45 M (90%) 5 F (10%) 27.5 f 4.5

NS

NS

24 6 19f6

27 8 14 1 21 +6

68f 19 67f23 30*37 60+40 71 f28 74+ 16 68f23 52+ 18

67f. 17 66f21 25 f 36 46 f 43 64f21 72f 15 67f20 51 f16

NS NS NS NS NS NS NS NS

42 11

NS NS

NS

infarction

risk patients into the home program, and only the highest risk patients were excluded from either program.

Methods Effects of a 3-month transtelephonically monitored home exercise program were compared with effects of on-site exercise rehabilitation program at 5 study sites. Study sites included The University of Vermont, The Cleveland Clinic, Emory University, Temple University, and Montefiore Medical Center. Patients entered the protocol within 3 months of an acute coronary event. The index diagnosis was coronary artery bypass grafting for 52% (n = 69), acute myocardial infarction for 16% (n = 19), coronary angioplasty for 29% (n = 38), and cardiac transplantation for 5% (n = 7). Patients were excluded from study participation far any of the following reasons: a history of ventricular fibrillation not in the setting of an acute myocardial infarction, documented exertional, sustained ventricular or supraventricular tachycardia, low threshold angina (~5 metabolic equivalents), 23 mm ST-segment depression during exercise stress testing, exercise-induced hypertension (>230 mm Hg), or left bundle branch block (from inability to monitor ECG for ischemia). Selection of the study intervention was not randomized, but rather, as in a clinical setting, subjects entered the home-based transtelephonically monitored program if the on-site program was geographically remote, which was the most common factor, or if work or schedule conflicts precluded on-site participation. Patients participated in an an-site program if it was geographically available to them and they were able to attend without work or schedule conflicts. Au patients signed an informed consent and underwent similar baseline screening and data collection by the same study personnel. This study was approved by the institutional review boards for human experimentation at each of the study sites.

Exercise capacity Before entering the rehabilitation protocol, all candidates underwent a baseline graded symptom-limited exercise test, with electrocardiographic monitoring and expired gas analysis measured with a metabolic cart. Patients in the on-site program performed their baseline testing an the treadmill because this was to be their primary training modality, whereas patients in the home program performed their exercise testing on a cycle ergometer because they were to train primarily on a stationary bicycle. Baseline data collection also included height, weight, body mass index in kilograms per square meter, and administration of the Health Status Questionnaire. II Quality of life Self-reported quality of life was measured before and after the rehabilitation program with the Health Status Questionnaire.” This instrument measures 8 domains of patient health status: general health perception, physical function, role limitations-physical, role limitations-emotional, social function, mental health, bodily pain, and energy/fatigue. Exercise rehabilitation protocols Both exercise protocols were characterized by the adminis tration of a progressive, individualized monitored exercise program. In both programs, nursing-based guidance and support was provided with an informal cardiac education program. The ScottCare Tele-Rehab system (ScottCare Corp, Cleveland, Ohio) was centralized at Raytel Cardiac Services, Inc (Forest Hills, NY). Raytel Cardiac Services had available multiple long+& tance phone lines to monitor up to 8 patients simultaneously. Patients were given a patient kit that included bipolar ECG leads, an ECG transmitter unit, a headset, a voice transmitter, and a telephone modem and were instructed in simple terms

American

Heart Journal

Volume 139, Number

Table

Ades

3

II. Response

to cardiac

rehabilitation

Horndared preconditioning Peak VO, Peak workload (w) Weight Health status questionnaire Health perception Physical functioning Role limitations-physical Role limitations-emotional Social functioning Mental health Bodily pain Energy/fatigue

l

P < ,001 compared

et al 545

19.2 + 5.5 106f36 82.7 k 15.0 68_+19

67f23 3oa37 60f40 71f28 74f16 68f23 52k18

Home-based postconditioning

On-site preconditioning

22.7 f 7.3* 132+40* 84.2 f 15.2

Odte postconditioning 26.1 f 8.3' 159+32* 82.6f 17.3

21.2k5.6 131f34 83.0 I? 17.4

74f19 81+21* 72f38* 78k37' 85+22* 75+19 83+18* 64+21*

P value for between group response

67f17 66f21 25k36 46+43 64f21 72f15 67+20 48+16

NS NS

c.05

73f17 86f15* 75f36* 77+.33* 83f20* 80+16 85+14* 67f17*

NS NS NS NS NS NS NS NS

with baseline value.

on its use. During the exercise sessions, patients were in direct telephone contact with the nurSe coordinator and with other patient participants. Patients began each exercise session with a warm-up and stretching routine and proceeded to their cycle exercise routine. Based on the initial evaluation, patients began with continuous or intermittent exercise of 15- to 25minute duration at 65% of their maximal measured heart rate. With the guidance of the nurse coordinator, patients gradually increased the exercise intensity to 85% of maximal heart rate for a total duration of 35 to 40 minutes of cycle exercise per session. Exercise intensity for cardiac transplant recipients was guided by the Borg perceived exertions scale and maintained at an intensity of 13 to 14 (“somewhat hard”). Patients were provided with a Tunturi Executive Ergometer (Redmond, Wash) for use during the exercise program. The nurse coordinator was given an automated emergency telephone number for each patient’s closest ambulance service for emergency contact. Patients were required to have another adult present in the home during the exercise sessions as an additional safety precaution. Patients who participated in the on-site exercise program primarily performed treadmill exercise for 25 to 30 minutes per session supplemented by 5 to 10 minutes on other apparatuses, which included cycle ergometers, rowing ergometers, and arm ergometers. Total exercise duration in this group progressed up to 40 to 50 minutes per session. In general, these patients were monitored electrocardiographically for their first 4 to 6 sessions with exercise intensity guided by a pm gressive heart rate prescription of 65% to 85% of their maximal measured heart rate from the baseline stress test. After the s-month. 3Gsession exercise program, patients in both experimental groups returned to the study site for exit stress testing and data collection as described on entry. Patients in both groups received a preventative education program. In the home group the education was delivered during the conference calls in an informal manner with the American Heart Association “Active Partnership” program. In the on-site group patients participated in 12 hours of group seminars that included risk factor teaching, stress management, and nutrition teaching. Knowledge outcomes were not measured.

Statistics Baseline comparisons between study groups were made with unpaired I tests. Response to exercise conditioning between study groups was analyzed with 2-way analysis of variance. Simple linear regression was used to assess relations between study variables.

Results Rehabilitation outcomes were compared in 83 patients who completed the transtelephonic homemonitored program versus 50 patients who completed the standard, on-site rehabilitation program. The dropout rate for the 2 groups was similar; 9% (8 of 91) in the home-monitored program and 8% (4 of 54) in the on-site

control

group

(P = not

significant

[NS]).

It took

13.5 weeks for the home group to complete the 12week program versus 13.9 weeks for the on-site group (P = NS). The 2 study groups were similar at baseline by age, sex, body mass index, diagnostic distribution, peak aerobic capacity (Feak Vo,), and Health Status Questionnaire scores (Table l). At baseline, the female patients were characterized by a similar age (55.7 f 8 vs 55.5 f 10 years) and quality of life scores (both P = NS) as the male patients, although they had a higher body mass index (30.1 f 4.4 kg/m* vs 28.1 f 4.1 kg/m*) and a lower peak Vo, (15 f 6 vs 20 * 6 mL/kg/min)(both P c .05) than the men. In both men and women at baseline, there was a correlation between advancing age and lower physical function scores (r = -0.25, P c .05). From a relative point of view, older patients (265 years) improved their aerobic capacity and quality of life scores similar to younger patients (P = NS between groups for both). After rehabilitation, both groups showed similar improvements in Peak Vo,, Peak workload and quality of life scores (Table II, Figure 1). Peak Vo, increased by

American

546

Ades

et 01

Figure

1

Hospital-Based

,oo Transtelephonic

1 I

Response tation. .05

of selected Each

level.

significant.

quality

of life domains

post-rehabilitation

Chonges Funct,

between Function;

measure groups Role

Phys,

for

to cardiac

was

significant

each

measure

role

rehobiliat P < were

not

limitations-physical.

Heart Joutnal March 2OCO

in the transtelephonic group and 14,700 f 6300 to 13,800 + 3100 in the on-site group (both P < .05, P = NS between groups). Submaximal Vo, was not altered by conditioning in either group, although the perceived exertion score at this standard workload was lower in both groups: 11 f 3 to 10 f 2 in the transtelephonic group vs 11 f 2 to 9 f 2 in the on-site group (both P < .05; P = NS between groups). The frequency of adverse events and cardiac events were closely followed in both groups. In the transtelephonic group a total of 3100 sessions of monitored exercise were accomplished without any major adverse events. A total of 7 sessions were canceled because of the development of untoward symptoms or rhythms; these include 2 for low-threshold angina, 3 for severe exertional dyspnea, and 2 for new rhythm abnormalities (atrial fibrillation and nonsustained ventricular tachycardia). The occurrence of stable threshold exertional angina or nonsustained arrhythmias were not deemed an absolute indication to cancel a session, although exercise intensity would be diminished and/or nitroglycerin administered. Such events would, however, be reported to the treating physician on a regular basis, as in the on-site program. There were no exercise-related deaths, cardiac arrests, or myocardial infarctions in either group.

Discussion 18% in the transtelephonic group and by 23% in the onsite group (both P < .OOl compared with baseline; P = NS between groups). There was a slight but significant difference in the body weight response during rehabilitation between the 2 study groups. The home group increased body weight from 82.7 f 15 kg to 84.2 f 15 kg whereas the on-site rehabilitation group weight decreased slightly from 83 f 17 kg to 82.6 f 17 kg (P c .05 between groups). This may have been caused by a greater exercise-related caloric expenditure in the onsite group, although that was not specifically measured. Alternatively, the on-site exercise group may have received more effective dietary counseling regarding weight control during the 3-month study period. Several of the quality of life domains showed a signiticant improvement after rehabilitation with no difference in response between the 2 rehabilitation interventions (Figure 1). These include significant improvements in physical functioning, social functioning, physical role limitations, emotional role limitations, bodily pain, and energy/fatigue. Analysis of hemodynamic data during submaximal exercise documented that at a standard fixed workload, the heart rate/systolic blood pressure product, an index of myocardial oxygen demand, was significantly lower after rehabilitation in both study groups, with no difference between groups (16,800 f 5100 to 14,900 f 4100

Despite the wellestablished benefits of cardiac rehabilitation after a major coronary event, only 15% of eligible patients in the United States actually participate.1 Factors related to nonparticipation include geographic nonavailability of programs, transportation or work constraints, patientcentered demographic characteristics (age, sex, marital status, etc), medical contraindications and physician nonreferral.4~13 A major effort is underway to expand the use of cardiac rehabilitation and secondary prevention services beyond the confines of the rehabilitation facility to include home-based, medically directed programs.83 11 Concerns regarding the value of home rehabilitation programs relate both to safety and to the attainment of a broad array of clinical outcome goals that have been demonstrated with on-site cardiac rehabilitation. In this study, a model of transtelephonically monitored homebased rehabilitation was evaluated by comparing outcome results of home-based rehabilitation with outcomes in patients who participated in more standard on-site rehabilitation at 5 well-established cardiac rehabilitation programs. The home group exercised on a stationary cycle ergometer with direct communication with a cardiac rehabilitation nurse and a simultaneous conference call with other rehabilitation patients. Only highest risk patients were excluded from entering this study (primarily exertional arrhythmias or very low threshold angina). Patients were not randomly assigned

American Heart Journal Volume 139, Number 3

to the home or on-site training groups, but participated in the home program, after informed consent, if they were unable to attend the on-site program because of geographic or work limitations. The 2 study groups were comparable at baseline by age, sex, fitness, and quality of life measures. We found that both groups increased their maximal work capacity and quality of life measures similarly despite the fact that the on-site patients performed a slightly higher volume of rehabilitation exercise. The home-based patients subjectively described that a high degree of psychosocial support resulted from the direct contact with the rehabilitation nurse and the contact with other patients by conference call. It is therefore difficult to determine whether improvements in quality of life reported in both groups were exercise-related or caused in part by the psychosocial support component of each program. The electrocardiographic monitoring was primarily used to adjust the intensity of exercise because there were no exercise-related emergencies. Only 7 sessions were terminated prematurely: 2 for pre-exercise arrhythmias, 2 for low-threshold angina, and 3 for low-threshold dyspnea. Each of these encounters resulted in a change of therapy for the patients involved. There were no exercise-related complications in the home group during 3100 hours of exercise. Other investigators have found a similarly low rate of exercise-related complications, including a retrospective survey of more than 14,000 transtelephonic sessions where no emergency medical services responses were reported.‘* Our prospective investigation was the first to include quality of life data and an on-site control group. It allowed participation of patients at a moderately high risk of cardiac complications. The challenge to cardiac rehabilitation specialists will be to apply this technology in a selective manner. Certainly, in low- to moderate-risk patients, all patients would not require full transtelephonic monitoring for all sessions. Rather, models of delivery will need to be evaluated in which a selective use of this technology-for example, the initial 3 to 6 sessionswould be monitored, with intermittent monitoring thereafter, either transtelephonically or on-site based on individual patient characteristics and progress assessments by the nurse specialist. Such an approach would be less expensive than standard %-session onsite programs and would reach patients not currently being served. In a clinical setting, the primary costs for establishing a transtelephonically monitored program are for the Scott-Care Tele-Rehab system, a cycle ergometer, phone contact, and nurse supervision. Total real costs for establishing a program are similar to costs for an on-site ECG-monitored program. Although the Medicare program in the United States requires an on-site physician to qualify for reimbursement, other private insurers and health

Ades

eta1

maintenance organizations often cover the charges for transtelephonic sessions if all the components of on-site cardiac rehabilitation are present. Medicare has provided coverage if the exercise component is delivered in a remote hospital setting with a physician present, with the monitoring and supervision provided at a larger, more central site. The results of this study are consistent with earlier reports of home rehabilitation in low- to moderate-risk patients.597 It appears that for the majority of home rehabilitation patients a safe home exercise program and an aggressive risk factor modification component can be delivered without the necessity for transtelephonic monitoring.*~9 Online monitoring appears to allow us to extend rehabilitation benefits to higher risk patients who are isolated from the cardiac rehabilitation facility. Limitations of this study include a lack of a nonexercise control group. Furthermore, although it was controlled, it was not a randomized, controlled study. Finally, it was an exerciseonly study without measurement of coronary risk factors. It nonetheless presents a model for use of a new technology and mode of delivery in preventive cardiology, such that the benefits of cardiac rehabilitation can be extended to an increased number of patients isolated from the rehabilitation facility. We thank Susan &egg and Charles Dente, PbD, of Raytel Cardiac Servicesfor their support. In addition we thank Patrick Savage, MS, Claire Young, RN, and Bonnie Smith, RN, for coordinating data collection andpatientflow. We also thank Donald K. Shaw, PbD, and Eric T. Poeblman, PbD, for reviewing this manuscrzpt.

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are

ore available:

issues

mointoined 25%

1 for information moy

14 100 or (800)

be

off

Services,

purchased 52 l-0600.

on