Peripheral Arterial Disease Clinical Trial
Official title:
Feasibility, Acceptability, and Outcomes of the "RESPONSE-2" Program in Reducing Sedentary Behavior in Patients With Peripheral Arterial Disease: A Mixed Methods Pilot Study
The RESPONSE-2- peripheral arterial disease (PAD) program will be implemented to modify sedentary time in patients with PAD. It is an adapted version of the RESPONSE that aims to reduce sedentary behavior in individuals with diabetes. The RESPONSE-2-PAD is a multicomponent program involves an online educational component, sedentary reminders and health coaching sessions, which are designed to modify patients' sedentary behavior.
Peripheral arterial disease (PAD) affects more than 230 million patients globally. PAD is characterized by a reduction in arterial perfusion caused by atherosclerotic plaque. PAD can negatively impact a person's quality of life due to the functional limitations caused by symptoms and the possibility of losing limbs. It also increases the risk of major adverse cardiac events (MACE). Many risk factors have been identified for PAD. Recently, sedentary behavior (SB) has emerged as an important risk factor for cardiovascular disease (CVD) including PAD independent to physical activity. Studies have reported that patients with PAD have significantly higher levels of total sedentary time (ST) compared to those without PAD. Consequently, early intervention and management strategies, including addressing sedentary behavior, are crucial to prevent unfavorable outcomes in patients with established PAD as it is possible for an individual to engage in a significant amount of moderate to vigorous physical activity and have high levels of sedentary time within the same day. The RESPONSE-2-PAD program will be evaluated in a pilot study involving 50 patients living with peripheral arterial disease. They will be recruited through the vascular services at University Hospital Galway. Those potentially interested will be provided with an information sheet. Participants will take part in an initial assessment which will measure their sitting time, physical activity participation and their six-minute walking distance. They will then take part in a 12-week individually tailored, coaching-based intervention. This intervention will be delivered remotely. The intervention involves the use of an activity tracker(sedentary reminder) and an online structured education program coupled with coaching calls (10-15minutes) that review sitting time and activity goals weekly. At 12-weeks all participants will be invited to a follow up assessment where sitting time, activity participation and six-minute walking distance will be remeasured. Patients will also be invited to take part in a semi-structured interview to explore their views and opinions of the program and its acceptability. At six months all patients will be invited for a final follow-up measurement of their sitting time, physical activity participation and six-minute walking distance in order to evaluate longer term changes. ;
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