Safety of Home-based Exercise for People with Intermittent Claudication: A Systematic Review

Waddell, Alexander; Seed, Sally A; Broom, David; McGregor, G.; Birkett, Stefan T; Harwood, Amy

doi:10.1016/j.jvs.2022.01.004

Cited by 4 publications

(3 citation statements)

References 4 publications

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“…Whilst some randomised controlled trials included in the meta-analysis excluded participants based on limited exercise capacity due to comorbidities, the all-cause complication rate of one per 10 340 patient hours was low [81]. Home-based exercise programmes for people with intermittent claudication also have low adverse event rates (all-cause complication rate of one event per 36 953 exercise hours), even in trials without pre-enrolment cardiac screening [82]. The safety of exercise in people with cardiovascular disease is corroborated by the Functional Evaluation and Cardiac Rehabilitation Working Group evaluation of registry data on complications during cardiac rehabilitation, which reported a rate of one adverse event per 49 565 patient hours [83].…”

Section: Discussionmentioning

confidence: 99%

Inequity in exercise-based interventions for adults with intermittent claudication due to peripheral arterial disease: a systematic review

Bearne

Delaney

Nielsen

et al. 2022

Disability and Rehabilitation

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Purpose: To determine the equity in access to trials of exercise interventions for adults with intermittent claudication due to peripheral arterial disease. Methods: Systematic electronic database searches of MEDLINE, Embase, CINAHL, Cochrane Central Register of Controlled Clinical Trials, PEDRO, Opengrey, ISRCTN and ClinincalTrials.gov for randomised controlled trials of exercise interventions for adults with intermittent claudication were conducted. Data extraction was informed by Cochrane's PROGRESS-Plus framework.Results: Searches identified 6412 records. Following the screening of 262 full texts, 49 trials including 3695 participants were included. All trials excluded potential participants on at least one equity factor. This comprised place of residence, language, sex, personal characteristics (e.g., age and disability), features of relationships (e.g., familial risk factors) and time-dependent factors, (e.g., time since revascularisation).Overall, 1839 of 7567 potential participants (24.3%) were excluded based on equity factors. Disability was the most frequently reported factor for exclusions. Conclusion:Trialists endeavour to enrol a representative sample in exercise trials whilst preserving the safety profile of the intervention. This review highlights that these efforts can inadvertently lead to inequities in access as all trials excluded potential participants on at least one equity factor. Future exercise trials should optimise participation to maximise generalisability of findings. PROSPERO registration no. CRD42020189965. � IMPLICATIONS FOR REHABILITATION� Equity factors influence health opportunities and outcomes. � All trials of exercise for people with intermittent claudication excluded adults on at least one equity factor. � Disability was the predominant factor for exclusions from trials. � Trials should optimise participation to maximise generalisability of results as these findings are used to inform treatment and service design.

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Section: Discussionmentioning

confidence: 99%

Inequity in exercise-based interventions for adults with intermittent claudication due to peripheral arterial disease: a systematic review

Bearne

Delaney

Nielsen

et al. 2022

Disability and Rehabilitation

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“…Third, we captured physical activity data using Fitbit devices, which were selected for this pragmatic clinical trial because they are widely available, easy for participants to use, and could be feasibly implemented if similar interventions were deployed in clinical practice. Although concerns have been raised about the accuracy of Fitbit devices relative to research-grade accelerometers or other criterion standards, 42,43 all participants received the same device, comparisons were between randomized groups, and any inaccuracy would not lead to systematic bias. Finally, the trial was powered to detect a 750-step difference among groups in mean daily steps during the main intervention period and was not powered to detect changes in MVPA or changes from baseline through the postintervention follow-up period.…”

Section: Limitationsmentioning

confidence: 99%

Effect of Gamification, Financial Incentives, or Both to Increase Physical Activity Among Patients at High Risk of Cardiovascular Events: The BE ACTIVE Randomized Controlled Trial

Fanaroff,

Patel,

Chokshi

et al. 2024

Circulation

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Background: Physical activity is associated with a lower risk of major adverse cardiovascular events, but few individuals achieve guideline recommended levels of physical activity. Strategies informed by behavioral economics increase physical activity, but their longer-term effectiveness is uncertain. We sought to determine the effect of behaviorally-designed gamification, loss-framed financial incentives, or the combination on physical activity compared with attention control over 12-month intervention and 6-month post-intervention follow-up periods. Methods: Between May 2019 and January 2024, participants with clinical ASCVD or 10-year risk of myocardial infarction, stroke, or cardiovascular death ≥ 7.5% by the pooled cohort equation were enrolled in a pragmatic randomized clinical trial. Participants received a wearable device to track daily steps, established a baseline, selected a step goal increase, and were randomly assigned to control (n = 151), behaviorally-designed gamification (n = 304), loss-framed financial incentives (n = 302), or gamification + financial incentives (n = 305). The trial’s primary outcome was change in mean daily steps from baseline through the 12-month intervention period. Results: A total of 1062 patients (mean [SD] age 67 [8], 61% female, 31% non-white) were enrolled. Compared with controls, participants had significantly greater increases in mean daily steps from baseline during the 12-month intervention in the gamification arm (adjusted difference, 538.0; 95% CI, 186.2-889.9; P = 0.0027), financial incentives arm (adjusted difference, 491.8; 95% CI, 139.6-844.1; P = 0.0062), and gamification + financial incentives arm (adjusted difference, 868.0; 95% CI, 516.3-1219.7; P < 0.0001). During 6-month follow-up, physical activity remained significantly greater in the gamification + financial incentives arm than in the control arm (adjusted difference, 576.2; 95% CI, 198.5-954; P = 0.0028) but was not significantly greater in the gamification (adjusted difference, 459.8; 95% CI, 82.0-837.6; P = 0.0171) or financial incentives (adjusted difference, 327.9; 95% CI, -50.2 to 706; P = 0.09) arms, after adjusting for multiple comparisons. Conclusions: Behaviorally-designed gamification, loss-framed financial incentives, and the combination of both increased physical activity compared with control over a 12-month intervention period, with the largest effect in gamification + financial incentives. These interventions could be a useful component of strategies to reduce cardiovascular risk in high-risk patients.

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“…Home-based exercise is safe, as described by a systematic review by Waddell and colleagues in this issue of the Journal. 13 Home-based walking exercise is also more convenient, does not require regular transportation, and because coaching contact is remote and typically less frequent than SET, is likely to be less costly than SET. Based on progress over the past 70 years, there is reason to remain highly optimistic that exercise therapy for PAD in the coming years will be even more effective and personalized, with greater uptake by all patients with PAD.…”

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confidence: 99%

Exercise therapy for peripheral artery disease in 2022: Progress and a prediction

McDermott

2022

Vasc Med

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Safety of Home-based Exercise for People with Intermittent Claudication: A Systematic Review

Cited by 4 publications

References 4 publications

Inequity in exercise-based interventions for adults with intermittent claudication due to peripheral arterial disease: a systematic review

Inequity in exercise-based interventions for adults with intermittent claudication due to peripheral arterial disease: a systematic review

Effect of Gamification, Financial Incentives, or Both to Increase Physical Activity Among Patients at High Risk of Cardiovascular Events: The BE ACTIVE Randomized Controlled Trial

Exercise therapy for peripheral artery disease in 2022: Progress and a prediction

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