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

NCT05961943 | Recruiting

• 1 other identifier: C.A.2970
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Sedentary Behavior; Sedentary Time; Peripheral Arterial Occlusive Disease

Keywords

peripheral arterial disease; sedentary lifestyle; Sitting time

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

• 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

Study Arms (1)

RESPONSE-2-PAD

EXPERIMENTAL

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

Interventions

RESPONSE-2-PAD BEHAVIORAL

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.

RESPONSE-2-PAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute for Prevention and Cardiovascular Health, Ireland: lead

Study Sites (1)

National Institute for prevention and Cardiovascular Health

Galway, H91 FF68, Ireland

RECRUITING

Related 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.

  PMID: 33741077 BACKGROUND

• 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.

  PMID: 29482617 BACKGROUND

• 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.

  PMID: 25907181 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Sedentary Behavior; Peripheral Arterial Occlusive Disease 1

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior

Study Officials

• Jennifer Jones

  University of Galway

  PRINCIPAL INVESTIGATOR

• Wael Tawfick

  University of Galway

  STUDY DIRECTOR

• Charlotte Edwardson

  University of Leicester

  STUDY CHAIR

Central Study Contacts

Marwa Said

CONTACT

00353877374710; m.said2@nuigalway.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study recruitment will be conducted at the vascular outpatient clinic at Galway University Hospitals (GUH), Ireland. Those who consent will then be invited to attend a baseline assessment. All participants will be provided with an activPAL accelerometer device to use for seven consecutive days. Patients will also complete the six-minute walk test (6-MWT) using timed walk application. Participants will then commence the 12-week tailored intervention to empower participants to reduce/interrupt their sedentary time. Participants will have access to an online education session via the RESPONSE-2-PAD link. The researcher will support and motivate participants to reduce/interrupt their sitting time by contacting them through phone or video coaching calls once a week, on average lasting 10-15 minutes. an activity tracker will be used as a sedentary reminder. Participants will be followed up at 12-weeks and again at six months.

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 27, 2023
• Study Start: September 29, 2023
• Primary Completion: January 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available to the other researchers on request for 5 years
• 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.

Locations

IE (1)