Long-Term Effects of Structured Home-Based Exercise Program on Functional Capacity and Quality of Life in Patients With Intermittent Claudication
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Abstract
Fakhry F, Spronk S, de Ridder M, den Hoed PT, Hunink MGM. Long-term effects of structured home-based exercise program on functional capacity and quality of life in patients with intermittent claudication.
Objectives
To evaluate effects of a structured home-based exercise program on functional capacity and quality of life (QoL) in patients with intermittent claudication (IC) after 1-year follow-up, and to compare these results with those from a concurrent control group who received supervised exercise training (SET).
Design
Comparative longitudinal cohort study.
Setting
Referral center.
Participants
Patients (N=142) with IC.
Interventions
Structured home-based exercise training or SET.
Main Outcome Measures
The maximum (pain-free) walking distance and the ankle-brachial index (ABI) (at rest and postexercise) were measured at baseline and after 6 and 12 months' follow-up. Additionally, QoL was evaluated using a self-administered questionnaire consisting of the Euroqol-5D (scale 0–1), rating scale (scale 0–100), Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36; scale 0–100), and the Vascular Quality of Life Questionnaire (VascuQol; scale 1–7). Comparison of the groups was performed with adjustment for the nonrandomized setting using propensity scoring.
Results
One hundred forty-two patients with IC started the structured home-based exercise program, of whom 95 (67%) completed 12 months' follow-up. The mean relative improvement compared with baseline was statistically significant after 12 months' follow-up for the maximum and pain-free walking distance (342%, 95% confidence interval [CI], 169–516; P<.01 and 338%, 95% CI, 42–635; P=.03, respectively) and for the ABI postexercise (mean change, .06; 95% CI, .01–.10; P=.02). For the QoL outcomes, the improvement compared with baseline was statistically significant after 12 months for the VascuQol (mean change, .42; 95% CI, .20–.65; P<.01) and for the SF-36 physical functioning (mean change, 5.17; 95% CI, .77–9.56; P=.02). Compared with the structured home-based exercise program, patients in the control group showed significantly better results in the mean relative improvement of maximum and pain-free walking distance and change in the ABI at rest after 12 months' follow-up.
Conclusions
Structured home-based exercise training is effective in improving both functional capacity and QoL in patients with IC and may be considered as a feasible and valuable alternative toSET, since supervised exercise programs are not often available.
Key Words:
Exercise, Intermittent claudication, Outcome assessment (health care), Peripheral arterial disease, Quality of life,RehabilitationList of Abbreviations:
ABI (ankle-brachial index), CI (confidence interval), IC (intermittent claudication), MPWD (maximum pain-free walking distance), MWD (maximum walking distance), PAD (peripheral arterial disease), QoL (quality of life), RCT (randomized controlled trial), SET (supervised exercise training), SF-36 (Medical Outcomes Study 36-Item Short-Form Health Survey),TASC (Trans-Atlantic Inter-Society Consensus for the Management of PAD), VascuQol (Vascular Quality of Life Questionnaire)
PERIPHERAL ARTERIAL DISEASE is a chronic atherosclerotic occlusive disease of the lower extremities. The classic symptom in patients with PAD is intermittent claudication (IC) (ie, Rutherford category 1, 2, or 3),1 affecting approximately 275,000 people older than 50 years in The Netherlands alone. Of these, half will have a cardiovascular event within 10 years (19% fatal, 27% nonfatal), resulting in more than 2500 deaths each year.2 Patients with IC have functional limitations because of impaired walking ability,3 and diminished quality of life (QoL).4
The treatment goals for patients with IC are to relieve symptoms and improve daily functional abilities and QoL. Previous studies have shown that exercise training should have a central role in the management of IC by significantly improving the MWD5, 6, 7 and QoL.8 A Cochrane review9 and a recent systematic review10 showed that SET is more effective than “go home and walk” advice. Furthermore, the American College of Cardiology and American Heart Association guidelines recommend SET as the initial treatment modality for patients with IC.11 In clinical practice, however, SET programs have a limited capacity in many centers.12 In addition, reimbursement for supervised exercise sessions depends on the patient's health insurance. Because of these limitations, many physicians in routine practice still advise their patients with IC to “go home and walk.” This approach, however, has many shortcomings including a high dropout rate and inadequate exercise as a result of minimal instruction.
A better alternative to this simple “go home and walk” advice may be a structured home-based exercise program in which additional instructions, encouragement, and motivation are offered to the patient during the program. Since the patient can exercise in a self-chosen environment, a structured home-based exercise program does not require the infrastructure and the logistics of supervised exercise programs and thus, if efficacious, may be implemented in current practice more easily.
The objective of this study was to evaluate the effectiveness of a structured home-based exercise program on both functional capacity and QoL in patients with IC after 6 and 12 months' follow-up, and to compare these results with those for a concurrent control group who received supervised exercise training (SET).
Methods
Study Design and Participants
This study was a comparative longitudinal cohort study following up patients with IC (Rutherford category 1, 2, or 3) for a period of 12 months. All patients with IC referred to the Department of Vascular Surgery by their general practitioner were considered for recruitment. Patients met the following inclusion criteria for a structured home-based exercise program: (1) older than 18 years; (2) Rutherford category (1, 2, or 3); (3) ankle-brachial index (ABI) less than 0.9 at rest, or ABI with a decrease of more than 30% after the treadmill test; (4) maximum pain-free walking distance (MPWD) less than 350m during a treadmill test; (5) and informed consent. Exclusion criteria were (1) patient eligible for concurrent RCT13, 14; (2) life-incapacitating cardiac disease; and (3) inability to complete a treadmill walking test for reasons other than claudication.
Patients who were eligible for a concurrent randomized controlled trial (RCT) and were allocated to SET served as controls. In this RCT, which was performed at the same hospital, results of SET and endovascular revascularization for patients with IC were compared after 12 months of follow-up. Inclusion criteria of this RCT were (1) Rutherford category 1, 2, or 3, with a duration of 3 months or more; (2) MPWD less than 350m; (3) ABI less than 0.9 at rest, or ABI decreasing by greater than .15 after the treadmill test; (4) 1 or more vascular stenoses of greater than 50% diameter reduction at the iliac or femoropopliteal level; and (5) informed consent. Exclusion criteria were (1) abdominal aortic aneurysm; (2) life-incapacitating cardiac disease (New York Heart Association classification II and higher); (3) multilevel disease (ie, same-side stenoses at both the iliac and femoral levels, requiring multiple revascularization procedures); (4) isolated tibial artery disease; (5) lesions deemed unsuitable for revascularization (iliac or femoropopliteal Trans-Atlantic Inter-Society Consensus for the Management of PAD (TASC) type D and some TASC type B and/or C lesions24); and (6) prior treatment for the lesion (including exercise training). Institutional review board approval was obtained, and all patients gave written informed consent.
Risk Factor Modification
Before starting either a structured home-based exercise program or a supervised exercise program, baseline data were obtained for all patients including cardiovascular risk factors, concomitant diseases, medical therapy use, previous vascular interventions, and a self-administered QoL assessment by questionnaire. Patients with 1 or more risk factors for cardiovascular disease were referred to a physician for secondary prevention according to the European Society of Cardiology guidelines on cardiovascular disease prevention in clinical practice.15
Interventions
Structured home-based exercise program
Before initiating the exercise program, a treadmill test at the vascular laboratory established patients' initial MPWD and maximum walking distance (MWD). The patients were instructed to accomplish daily exercise sessions, at least 1 session daily, during 24 weeks in a self-chosen environment. In addition, patients were advised to include regular walks in their daily routine. Each subject received an information sheet with instructions regarding the exercise regimen, which consisted of approximately 30 minutes of walking during each exercise session, started with the initial walking speed, and involved walking near-maximum claudication pain, alternated with 1 minute of walking at a very low pace until the pain abated.16 Evaluation of the walking distance took place after 2, 8, 16, and 24 weeks at the vascular laboratory by a vascular technologist. During these 1-hour individual follow-up sessions, the patient's progress was assessed by establishing the patient's MWD and MPWD, and discussing the approximate number of sessions and duration of each exercise session the patient had performed. New targets regarding walking speed, walking distance, and compliance were given to the patient. Problems experienced by the patient during the exercise program were discussed, and additional instruction on exercise performance was given. Education about the treatment of IC and the presently known results and advantages of exercise training on IC and atherosclerotic risk factors was given to the patients every session. The patients were also strongly encouraged to keep up the recommended exercise program and to perform at least 1 exercise session daily. After completion of the 24-week program, patients were advised to include home-based exercise training in their daily routine.
Control group
All patients in the nonrandomized control group started with SET for a period of 24 weeks, 2 sessions weekly. The exercise session consisted of 30 minutes of walking on a treadmill at a workload of 3.5km/h without a graded incline and was supervised by a vascular technologist. Patients walked to near-maximum claudication pain, then decreased the workload and continued exercising at this reduced workload until the pain subsided, after which the workload was increased again.13 After completion of the 24-week supervised program, these patients were also advised to walk on a daily basis.
Outcomes
The outcome variable was effectiveness, which was defined as improvement compared with baseline in both functional capacity and QoL after 6- and 12-month follow-up.
Improvement in functional capacity was assessed by MWD and MPWD after treadmill walking (speed 3.5 km/h, no graded incline), and by the ABI at rest and postexercise determined by Doppler pressure measurements. Trained vascular technicians assessed these parameters. For practical reasons the maximum walking time was 30 minutes.
Improvement in QoL was assessed by a self-administered questionnaire. This patient-reported questionnaire consisted of the Euroqol-5D, rating scale, Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), and the Vascular Quality of Life Questionnaire (VascuQol) instruments.
The Euroqol-5D instrument assesses QoL values from the societal perspective and classifies patients into a health-state. It covers 5 QoL dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.17 We used the Dutch scoring algorithm, which was derived from the general population, to value each health state between 0 and 1, where 0 indicates death and 1 indicates maximum health.18
The rating scale instrument asked the patients to rate their overall health on a scale from 0 to 100, where 0 represents death and 100 perfect health.19
The SF-36 instrument contains 36 questions and evaluates the general health and well-being of patients through 8 different health domains.20 Previous studies demonstrated that only physical functioning, role-functioning limitations caused by physical problems, bodily pain, and general health are the most relevant health domains to describe the health status of patients with peripheral arterial disease (PAD),14, 21 so we restricted this analysis to these 4 domains. The SF-36 was valued on a 0- to 100-point scale; 0 reflected worst health, and 100 indicated maximum health.
The VascuQol instrument consists of 25 questions.22 For each question there is a 7-point response scale, with 1 reflecting the worst possible QoL and 7 the best possible QoL.
Statistical Analysis
Continuous data are presented as means and SDs. Discrete data are given as numbers and percentages. Changes in the outcome measures are expressed as mean improvements compared with baseline and 95% CIs, except for the dependent variables MWD and the MPWD which are given as mean relative improvements due to the skewness of these data.23
To assess the differences in baseline characteristics between the patients who received the structured home-based exercise program and the control group, we used the unpaired t test or the Mann-Whitney U test, as appropriate, whereas dichotomous outcomes were assessed with the chi-square test.
Significance of change in the outcome measures was assessed with mixed effects models for repeated measures. An advantage of this repeated-measures approach is that it allows for inclusion of patients with missing follow-up data, due to random withdrawal, in the analysis. Where applicable, a linear mixed model was applied to the original outcome. Otherwise, in case of the MWD and the MPWD, we used a transformation to a relative improvement compared with baseline. We adjusted the model for the following potential confounders, based on clinical judgment and the literature: sex, age, smoking, hypertension, diabetes mellitus, and hyperlipidemia.24
To compare the differences in outcome measures between the structured home-based exercise program and the control group, we performed a propensity score–adjusted repeated-measures analysis. We first computed a propensity score by using a multivariable logistic regression analysis with treatment group as the dependent variable and baseline characteristics related to the outcome as independent variables.25 We then entered the propensity score into a linear mixed model as a continuous variable to adjust for all observed potential imbalance between the 2 treatment groups. In our modeling approach, we first assumed a general model for the mean structure, and sought the simplification of the variance-covariance matrix structure. After all possible dependencies were eliminated, we proceeded with an elimination of the mean structure parameters.
Results
Patients
A total of 298 patients with IC were referred to the Department of Surgery. One hundred fifty-one patients were excluded based on the exclusion criteria. Five patients never started the structured home-based exercise program for various reasons (fig 1) and were therefore also excluded from further analysis. Thus, the final study population consisted of 142 patients. Ninety-five of the 142 patients (67%) completed 12 months' follow-up. The remaining 47 patients discontinued the study for various reasons (see fig 1).
Fig 1
Flow chart of the total population eligible for structured home-based exercise program. Abbreviation: CVA, cerebrovascular accident.
The baseline characteristics of the patients are presented in table 1. There were no statistical significant differences in baseline characteristics between patients from the structured home-based exercise program group and patients from the control group, except for smoking and level of disease (see table 1).
NOTE. Values are mean ± SD or n (%) unless otherwise indicated.
Abbreviation: NS, not significant.
Score, 0 to 100 (worst-best) scale.
†Score, 0 to 1 (worst-best) scale.
‡Score, 1 to 7 (worst-best) scale.
Outcomes
The adjusted mean relative improvement in MWD compared with baseline after 6 months of structured home-based exercise was 364% (95% confidence interval [CI], 200–528; P<.01) and was statistically significant (table 2). After 12 months' follow-up, this adjusted relative improvement was still statistically significant (improvement 342%; 95% CI, 169–516; P<.01). The adjusted mean relative improvement in MPWD after 6 months compared with baseline was 269% (95% CI, –60 to 597; P=.10), which was not statistically significant. After 12 months' follow-up, this adjusted mean relative improvement was statistically significant with an improvement of 338% (95% CI, 42–635; P=.03) (see table 2). Although there were no significant differences in the ABI at rest after 6 and 12 months' follow-up, the mean change in ABI after exercise was significantly better after follow-up compared with baseline. After 6 months, the mean change was .04 (95% CI, 0.00–.07; P=.04). After 12 months, this improvement was still statistically significant and increased to .06 (95% CI, .01–.10; P=.02).
Abbreviation: NS, not significant.
Adjusted for sex, age, smoking, hypertension, hyperlipidemia, and diabetes mellitus.
†Presented as mean relative improvement.
The adjusted mean change in QoL after 6 months compared with baseline was statistically significant for the VascuQol (scale 1–7) with a mean change of .37 (95% CI, .17–.56; P<.01) (table 3), and for the SF-36 physical functioning scores (scale 0–100) with a mean change of 5.96 (95% CI, 2.04–9.87; P<.01). After 12 months, this improvement was still statistically significant for the VascuQol (mean change, .42; 95% CI, .20–.65; P<.01) and for the SF-36 physical functioning score (mean change, 5.17; 95% CI, .77–9.56; P=.02).
Abbreviation: NS, not significant.
Adjusted for sex, age, smoking, hypertension, hyperlipidemia, and diabetes mellitus.
†Score, 1 to 7 (worst-best) scale.
‡Score, 0 to 100 (worst-best) scale.
§Score, 0 to 1 (worst-best) scale.
Comparison of Groups
After adjustment for potential confounders, the patients in the control group showed significantly better results in functional capacity outcomes except for ABI after exercise (table 4). However, after adjustment, there were no significant differences in the QoL scores between the 2 groups at 6 or 12 months' follow-up, except for SF-36 general health domain (P=.03) and rating scale (P<.01) at 6 months' follow-up (table 5).
Abbreviation: NS, not significant.
Adjusted for sex, age, smoking, hypertension, hyperlipidemia, diabetes mellitus, and propensity score.
†Presented as mean relative improvement..
‡Negative difference indicates the difference between the 2 groups in favor of the control group.
Abbreviation: NS, not significant.
Adjusted for sex, age, smoking, hypertension, hyperlipidemia, diabetes mellitus, and propensity score.
†Score, 1 to 7 (worst-best) scale.
‡Negative difference indicates the difference between the 2 groups in favor of the control group.
§Score, 0 to 100 (worst-best) scale.
∥Score, 0 to 1 (worst-best) scale.
Discussion
The objective of this study was to evaluate the effectiveness of a structured home-based exercise program for patients with IC and to compare these results with those for a concurrent control group who received SET. We determined the improvement in both functional capacity and QoL after 6 and 12 months' follow-up and showed that a structured home-based exercise program was of significant benefit in improving MWD, MPWD, the ABI postexercise, and the QoL in patients with IC. However, compared with a supervised exercise program, the structured home-based exercise program was inferior in improving functional capacity. The improvement achieved in MWD and MPWD can also be considered clinically relevant, as patients improved their pretraining adjusted MWD and MPWD by 342% and 338%, respectively, after 12 months' follow-up, This is comparable with walking an additional 6 to 7 blocks until maximum claudication pain and can be considered as substantial improvement for patients with IC. However, compared with a supervised exercise program, the structured home-based exercise program was inferior in improving functional capacity.
Studies evaluating both functional capacity and QoL after structured home-based exercise program are scarce, and to our knowledge this is the first study that evaluated all these outcomes by using an unsupervised but structured approach. There are no meta-analyses on the effectiveness of structured home-based exercise programs. However, our results were consistent with those from previous RCTs, in which minimal supervision was added to their home-based exercise training group.26, 27
The results from the literature evaluating the effectiveness of the simple “go home and walk” advice are not comparable with our results because of the supportive element in our study. The improvement achieved in MWD after 12 months was larger in our study compared with studies evaluating the simple “go home and walk” advice.28, 29 An explanation for this difference is probably that our home-based exercise program was structured by intervening visits during the program in which we evaluated patients' progress, offered patients additional instructions, and motivated them to continue. Patients who follow the “go home and walk” advice but do not get any form of supervision and encouragement are more likely to stop the program than patients who get SET.30 The dropout rate in our study (33%) was low and comparable with the dropout rates from RCTs evaluating SET.31, 32, 33 An explanation for this “good” compliance might be that in our structured home-based exercise program the patient could perform the exercise sessions in a self-chosen environment and time, which might facilitate continuation of the program.
Study Limitations
Although we demonstrated significant improvement in functional capacity and QoL, there were some limitations of our study, which could have affected our results. First, our study sample was relatively small, which may limit the level of evidence of our study. Second, our study was a single-center study, nonblinded and nonrandomized. To adjust for the effect of nonrandomization we used a propensity score–adjusted analysis to compare the structured home-based exercise group with a control group. Although propensity score risk adjustment controls for the observed imbalance on background covariates between the treatment and control group, it does not take into account nonmeasured confounding variables that may have still caused a treatment selection bias. Next, we excluded the patients eligible for a concurrent RCT, which might have established an inherent bias in the selection of patients. However, at baseline, there were no statistically significant differences in severity of disease, functional capacity, and QoL outcomes between the patients in our study and patients from the concurrent RCT. Furthermore, we did not ask the patients to keep daily program records of their exercise sessions, and because the patients were not completely supervised, there could be a level of uncertainty about their exercise compliance. Because exercise compliance in an unsupervised exercise training program is very important but difficult to measure, a suggestion for future studies might be to use devices such as pedometers to monitor patients' activity.
Since patients in a structured home-based exercise program have the freedom to exercise in the convenience of their home setting, the patient compliance and QoL can be favorably influenced. For many patients it is difficult to attend regular activities that are outside their daily routine. Many patients with IC are physically inactive, which could reduce a patient's motivation to participate in a SET program, and emphasizes the need to explore the most convenient and feasible program in daily practice. Next, our analyses were limited to only those who completed the study. To deal with this limitation we included all patients in the analyses and used a repeated-measures approach, which has the advantage of allowing for the inclusion of patients with random missing follow-up data because of withdrawal. Still the possibility that those who withdrew from the study would have responded less favorably to exercise cannot be ruled out. Furthermore, at the time of the study protocol, a graded treadmill test was not available, and instead we used a speed of 3.5 km/h with a maximum of 30 minutes for practical reasons. However, a significant number of patients were able to walk longer than the limited 30 minutes, and the demonstrated improvement in the MWD after 6 and 12 months' follow-up may have been underestimated. Whereas patients in the control group exercised on a treadmill, patients in the structured home-based exercise program did not. This might have caused a familiarization for treadmill walking in the control group with a subsequent better performance when they were tested during follow-up, which could have led to overestimation of the difference in MWD and MPWD between the 2 groups in favor of the control group.
It is important to emphasize that our study was not designed to compare the effectiveness of a structured home-based exercise training group with a SET group. Our goal was to evaluate a structured home-based exercise program when a supervised program is not available. Implementing SET for IC in daily practice can be complicated. Many vascular surgeons do not have access to a rehabilitation center for carrying out SET because of limited capacity at the centers. A recent published study showed that despite all the recommendations from the TASC, and the American College of Cardiology and the American Heart Association guidelines to use SET in the management of IC,11, 24 only 24% of surgeons have access to SET.12 Furthermore, patients are often limited in their transport to the hospital or rehabilitation center in terms of costs and time. These limitations force the current practice of care for most patients to still consist of advice to “go home and walk.”
Economic evaluation of (structured) home-based exercise training versus SET is important but still relatively rare. A recent article from van Asselt et al34 evaluating the cost-effectiveness of SET compared with “go home and walk” advice concluded that at a willingness-to-pay threshold of €40 000 per quality-adjusted life year, SET is likely to be a cost-effective therapeutic option. However, in this study, SET was compared with advice to “go home and walk” and not with a structured home-based exercise program as we described. Although one would expect the structured home-based exercise to be less expensive, additional treatment costs after failure of a structured home-based exercise program need to be taken into account and could raise the costs. Therefore, further research with a full economic evaluation that includes consideration of all costs and consequences is needed.
To improve current practice, we showed that a structured home-based exercise program can be clinically more effective than the simple “go home and walk“ advice and should be used instead. We suggest that all patients with symptoms of IC should be treated with a SET program. If a SET program is not feasible, a structured home-based exercise program should be considered instead of the “go home and walk” advice.
Conclusions
A structured home-based exercise program is effective in improving both functional capacity and QoL in patients with IC and may be considered as a feasible and valuable alternative to a SET program, since supervised exercise programs are not often available in clinical practice.
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