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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease; Sedentary Behavior; Sedentary Time
• Intervention / Treatment: Behavioral: RESPONSE-2-PAD

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa Said; Phone Number: 00353877374710; Email: m.said2@nuigalway.ie

Study Locations

• Ireland
  • Galway, Ireland, H91 FF68
    • Recruiting
    • National Institute for prevention and Cardiovascular Health
    • Principal Investigator: Jennifer Jones
    • Contact: Wael Tawfick; Phone Number: 0035391542376; Email: wael.tawfick@hse.ie
    • Sub-Investigator: Wael Tawfick
    • Sub-Investigator: Marwa Said
    • Contact: NIPC Health; Phone Number: 0035391893299; Email: Jennifer.jones@universityofgalway.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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

Collaborators and Investigators

• Sponsor: National Institute for Prevention and Cardiovascular Health, Ireland
• Investigators: Principal Investigator: Jennifer Jones, University of Galway; Study Director: Wael Tawfick, University of Galway; Study Chair: Charlotte Edwardson, University of Leicester

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: peripheral arterial disease; sedentary lifestyle; Sitting time
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: C.A.2970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only the relevant data will be collected and stored in Galway university hospital. The data relevant to this study will only be stored for 5 more years after the thesis is written and the research has been published in peer-reviewed journals.
• IPD Sharing Time Frame: Data will be available to the other researchers on request for 5 years
• IPD Sharing Access Criteria: The data will be in an encrypted file and will be stored at a secure database in Galway University Hospital. Only the coded data information will be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No