Although supervised exercise programs for peripheral arterial disease (PAD) are highly effective, few people are able to successfully utilize these programs. Barriers that prevent patients from adopting and adhering to supervised exercise programs include lack of insurance reimbursement for walking exercise and poor proximity to hospitals and clinics as external barriers. Lack of knowledge about how to exercise and habitual sedentary behavior represent potential internal barriers. Community-based exercise programs for PAD have to date met with inconsistent results possibly due to lack of training and follow-up. Thus, more consistent and directed programs need to be established for community-based exercise training programs that also remove the external and internal barriers associated with supervised exercise training programs. Process evaluation needs to be implemented in community-based research, as this has not received virtually no attention in vascular medicine. The primary aim of the proposed study is to determine the effect of a community-based exercise program with training (T), monitoring (M) and coaching (C) (TMC) components to improve peak walking time (PWT) in PAD patients, which is the primary outcome of the study. We will test the hypothesis that PAD patients randomized to a community-based exercise program with TMC will improve PWT compared to patients who only receive usual care advice. A novel approach will be employed for the exercise treatment which includes a combination of exercise training (T), specific monitoring plans (M) and individual feedback/coaching (C). Training will focus on walking exercise using established guidelines for frequency (3 X per week for 12 weeks in the community), duration (35-50 minutes per session) and intensity (to initiate rest periods due to claudication pain in 3-5 min or production strategy using ratings of perceived exertion). Researchers will objectively monitor exercise of PAD patients using piezoelectric and spring-levered activity monitors to assess adherence to the program. Additionally, patients will be responsible for self-monitoring their activity in order to promote their sense of personal responsibility to maintain lifelong changes in habitual exercise. Finally, an operational coaching model that will provide training guidance and directly target local barriers to walking exercise in the community will be conducted (assessed by an initial community-based assessment of the patient's walking area using an environmental audit tool). Problem-solving on how to operationalize the training instructions will be an important step in order to use the local environment as a platform for exercise. In conclusion, TMC in community-based settings may be a ground-breaking program for improving health of PAD patients while circumventing many of the above barriers to exercise training.

PUBLIC HEALTH RELEVANCE: While supervised exercise is generally a first line therapy for patients with peripheral artery disease (PAD), it is considerably underutilized due to barriers such as inadequate insurance coverage and patient proximity to health care facilities. Virtually all community-based exercise training programs have proven unsuccessful due to the reliance on patient self-monitoring of the exercise routine. Thus, it is important to establish the effectiveness of a community-based exercise therapy model incorporating detailed components (e.g. training, monitoring and coaching) that, if successful, may serve as an alternative to supervised exercise therapy in hospitals for patients with PAD following endovascular therapy.

F32HL105095

2011-07-21

2012-07-20