Program to reduce sedentary time in patients with peripheral arterial disease

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

This study is testing a new program to help people with peripheral arterial disease move more and sit less to improve their health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Institute for Prevention and Cardiovascular Health, Ireland (Academic / other)
• Locations: 1 site (Galway)
• Trial ID: NCT05961943 on ClinicalTrials.gov

What this trial studies

The RESPONSE-2-PAD program aims to modify sedentary behavior in patients with peripheral arterial disease (PAD) through a multicomponent approach. This includes an online educational component, sedentary reminders, and health coaching sessions designed to encourage more active lifestyles. The program will be evaluated in a pilot study involving 50 patients recruited from University Hospital Galway, where their sitting time and physical activity levels will be assessed. The goal is to address the high levels of sedentary time that contribute to adverse health outcomes in PAD patients.

Who should consider this trial

Good fit: Ideal candidates for this program are adults aged 18 and older with symptomatic peripheral arterial disease confirmed by specific diagnostic criteria.

Not a fit: Patients with severe mobility impairments or significant comorbid conditions that limit their ability to participate in activities may not benefit from this program.

Why it matters

Potential benefit: If successful, this program could significantly improve the quality of life and health outcomes for patients with peripheral arterial disease by reducing sedentary behavior.

How similar studies have performed: While there is emerging evidence linking sedentary behavior to cardiovascular disease, this specific approach targeting PAD patients is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Adults (≥18 years),
2. 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.
3. Willing and able to give informed consent.
4. Can read and speak English.

Exclusion Criteria:

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

Where this trial is running

Galway

• National Institute for prevention and Cardiovascular Health — Galway, Ireland (Recruiting)

Study contacts

• Principal investigator: Jennifer Jones — University of Galway
• Study coordinator: Marwa Said

Conditions Peripheral Arterial Disease; Sedentary Behavior; Sedentary Time; Peripheral Arterial Occlusive Disease; peripheral arterial disease; sedentary lifestyle; Sitting time