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

Not Applicable

Recruiting

• Conditions: Sedentary Behavior; Sedentary Time; Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease
• Interventions: Behavioral: RESPONSE-2-PAD

• Registration Number: NCT05961943
• Lead Sponsor: National Institute for Prevention and Cardiovascular Health, Ireland

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-27
• Study Start: 2023-09-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-06
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-01
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RESPONSE-2-PAD	RESPONSE-2-PAD	All participants will use the activPAL accelerometer to quantify sedentary time/physical activity. The 6-minute-walk test will be assessed. Participants will receive the 12 week tailored intervention (RESPONSE-2-PAD link, coaching calls and activity tracker). Participants will be followed up at 12-weeks and again at six months.

Primary Outcome Measures

Name	Time	Method
Evaluating the impact of the Multicomponent Intervention (RESPONSE-2-PAD) on sedentary time in individuals with PAD.	Participants recruited for 6 months. Sedentary time assessed at baseline, after 12-week intervention, and at 6-month follow-up. Comprehensive evaluation of sedentary behavior throughout the study.	This study will assess sedentary time in hours at baseline. After a 12-week intervention and a 6-month follow-up, sedentary time will be reassessed using the activPAL accelerometer, as done at baseline. Data analysis will evaluate changes in sedentary time from baseline to post-intervention using statistical methods to assess the effectiveness of the multicomponent intervention.
Assessing the participant involvement in RESPONSE-2-PAD Intervention to Reduce Sedentary Time.	At the end of the 6-month follow-up period, participants will be interviewed to gather qualitative feedback.	This study aims to evaluate the level of participant engagement in the RESPONSE-2-PAD intervention, which is designed to reduce sedentary time. Through a semi structured interview. We will assess participants' involvement, motivation, and adherence to the intervention.

Secondary Outcome Measures

Name	Time	Method
Assessing the change in physical activity level in individuals with PAD using a Multicomponent Intervention (RESPONSE-2-PAD).	Participants recruited for 6 months. MVPA assessed at baseline, after 12-week intervention, and at 6-month follow-up.	Moderate to vigorous physical activity (MVPA) hours will be assessed at baseline. After the intervention period (12 weeks) and 6 months follow up will be reassessed using the activPAL accelerometer as before the intervention. Then data will be analyzed to assess the changes in MVPA from baseline to post-intervention. Statistical methods will be employed to compare pre- and post-intervention MVPA and evaluate the effectiveness of the multicomponent intervention.
Assessing the Efficacy of the RESPONSE-2-PAD Program Using the 6-Minute Walk Test (6MWT) to Improve Symptom-Free Walking Distance.	6-Minute Walk Test (6MWT) Assessments: Baseline: Before starting the intervention Post-Intervention: At the end of the 12-week intervention period Follow-Up: 6 months after the completion of the intervention	This study aims to evaluate the effectiveness of the RESPONSE-2-PAD program in improving symptom-free walking distance using the six-minute walking test (6MWT). The assessment will include measuring total meters scored, initial claudication distance, and absolute claudication distance in participants with peripheral arterial disease (PAD).

Trial Locations

Locations (1)

National Institute for prevention and Cardiovascular Health; 🇮🇪 Galway, Ireland