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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961943
• Other study ID #: C.A.2970
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: National Institute for Prevention and Cardiovascular Health, Ireland
• Contact: Marwa Said
• Phone: 00353877374710
• Email: m.said2[@]nuigalway.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease
• Peripheral Vascular Diseases
• Sedentary Behavior
• Sedentary Time

Intervention

Behavioral:
• RESPONSE-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.

Locations

Country	Name	City	State
Ireland	National Institute for prevention and Cardiovascular Health	Galway

Sponsors (1)

Lead Sponsor	Collaborator
National Institute for Prevention and Cardiovascular Health, Ireland

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

Bailey DP, Edwardson CL, Pappas Y, Dong F, Hewson DJ, Biddle SJH, Brierley ML, Chater AM. A randomised-controlled feasibility study of the REgulate your SItting Time (RESIT) intervention for reducing sitting time in individuals with type 2 diabetes: study protocol. Pilot Feasibility Stud. 2021 Mar 19;7(1):76. doi: 10.1186/s40814-021-00816-0. — View Citation

Chastin SFM, Dontje ML, Skelton DA, Cukic I, Shaw RJ, Gill JMR, Greig CA, Gale CR, Deary IJ, Der G, Dall PM; Seniors USP team. Systematic comparative validation of self-report measures of sedentary time against an objective measure of postural sitting (activPAL). Int J Behav Nutr Phys Act. 2018 Feb 26;15(1):21. doi: 10.1186/s12966-018-0652-x. — View Citation

Martin A, Fitzsimons C, Jepson R, Saunders DH, van der Ploeg HP, Teixeira PJ, Gray CM, Mutrie N; EuroFIT consortium. Interventions with potential to reduce sedentary time in adults: systematic review and meta-analysis. Br J Sports Med. 2015 Aug;49(16):1056-63. doi: 10.1136/bjsports-2014-094524. Epub 2015 Apr 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the impact of the Multicomponent Intervention (RESPONSE-2-PAD) on sedentary time in individuals with PAD.	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.	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.
Primary	Assessing the participant involvement in RESPONSE-2-PAD Intervention to Reduce Sedentary Time.	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.	At the end of the 6-month follow-up period, participants will be interviewed to gather qualitative feedback.
Secondary	Assessing the change in physical activity level in individuals with PAD using a Multicomponent Intervention (RESPONSE-2-PAD).	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.	Participants recruited for 6 months. MVPA assessed at baseline, after 12-week intervention, and at 6-month follow-up.
Secondary	Assessing the Efficacy of the RESPONSE-2-PAD Program Using the 6-Minute Walk Test (6MWT) to Improve Symptom-Free Walking Distance.	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).	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