RecruitingNot ApplicableNCT05961943

RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients

Feasibility, Acceptability, and Outcomes of the "RESPONSE-2" Program in Reducing Sedentary Behavior in Patients With Peripheral Arterial Disease: A Mixed Methods Pilot Study

Sponsor

National Institute for Prevention and Cardiovascular Health, Ireland

Enrollment

50 participants

Start Date

Sep 29, 2023

Study Type

INTERVENTIONAL

Conditions

Sedentary Behavior Peripheral Arterial Disease Sedentary Time

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Adults (≥18 years),
Symptomatic patients with established peripheral arterial disease. PAD is confirmed by any of the following:
Ankle-brachial index (ABI) of less than 0.90 in at least one lower extremity
Toe brachial index of less than 0.60
Arterial occlusive disease in one lower extremity by duplex ultrasonography, computed tomographic angiography or magnetic resonance angiography.
Willing and able to give informed consent.
Can read and speak English.

Exclusion Criteria5

patients with significant PAD in the form of rest pain.
Any impairments that severely affect mobility (e.g., wheelchair bound).
Cognitive impairments revealed by medical records.
Significant comorbid disease that would significantly impair the ability to participate in activity.
Pregnant / lactating females.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALRESPONSE-2-PAD

The RESPONSE-2-PAD program will undergo evaluation through a pilot study includes 50 patients living with peripheral arterial disease. Participants will take part in an initial assessment which will measure their sedentary time/physical activity using activPAL and their six-minute walking distance. They will then take part in a 12-week tailored, coaching-based intervention delivered remotely. The intervention involves the use of an activity tracker (sedentary reminder) and an online structured education program coupled with coaching calls that review sedentary time and activity goals weekly. At 12-weeks all participants will be invited to a follow up assessment. Participants 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 measurements.