Clinical trial NCT05961943: RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Sedentary Behavior
Sedentary Time
Peripheral Arterial Occlusive Disease
Keywords: peripheral arterial disease
sedentary lifestyle
Sitting time
Lead sponsor: National Institute for Prevention and Cardiovascular Health, Ireland
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Evaluating the impact of the Multicomponent Intervention (RESPONSE-2-PAD) on sedentary time in individuals with PAD.
timeFrame: 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.
measure: Assessing the participant involvement in RESPONSE-2-PAD Intervention to Reduce Sedentary Time.
timeFrame: At the end of the 6-month follow-up period, participants will be interviewed to gather qualitative feedback.
Secondary outcomes:
measure: Assessing the change in physical activity level in individuals with PAD using a Multicomponent Intervention (RESPONSE-2-PAD).
timeFrame: Participants recruited for 6 months. MVPA assessed at baseline, after 12-week intervention, and at 6-month follow-up.
measure: Assessing the Efficacy of the RESPONSE-2-PAD Program Using the 6-Minute Walk Test (6MWT) to Improve Symptom-Free Walking Distance.
timeFrame: 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
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: National Institute for prevention and Cardiovascular Health
Study officials:
affiliation: University of Galway
name: Jennifer Jones
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Galway
name: Wael Tawfick
role: STUDY_DIRECTOR
affiliation: University of Leicester
name: Charlotte Edwardson
role: STUDY_CHAIR
References:
citation: 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.
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.
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.