EFFECTIVENESS OF A BEHAVIOR CHANGE INTERVENTION AIMED AT INCREASING PHYSICAL ACTIVITY IN PATIENTS WITH PERIPHERAL ARTERY DISEASE UNDERGOING ENDOVASCULAR REVASCULARIZATION
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Moderate-to-vigorous physical activity (MVPA)
Study Overview
Brief Summary
The study titled "Investigation of the Effect of a Behavior Change-Based Physical Activity Program in Patients with Peripheral Artery Disease Who Have Undergone Endovascular Revascularization" will be conducted by Specialist Physiotherapist Ayşe ADIGÜZEL BAYAR. The study is designed to investigate the effects of a structured physical activity program planned using behavior change techniques after endovascular revascularization on walking capacity, physical function, physical activity level and quality of life in patients with peripheral artery disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female participants
- •Aged between 50 and 80 years
- •Able to read, understand, and write Turkish
- •Scheduled to undergo endovascular revascularization for peripheral artery disease
Exclusion Criteria
- •Positive exercise stress test result
- •Presence of cognitive or intellectual impairment
- •Presence of musculoskeletal or neurological conditions that may interfere with physical activity performance or outcome assessment
- •Presence of unstable chronic disease
Arms & Interventions
Behavior Change Intervention Group
Participants in this arm will receive a structured behavior change-based physical activity intervention following endovascular revascularization.
Intervention: Behavior Change-Based Physical Activity Program (Behavioral)
Supervised Exercise Group
Participants in this arm will receive a supervised exercise program following endovascular revascularization, without a structured behavior change component.
Intervention: Combined Behavior Change and Exercise Program (Other)
Combined Intervention Group
Participants in this arm will receive a combined intervention including both a behavior change-based.
Intervention: Supervised Exercise Program (Other)
Outcomes
Primary Outcomes
Moderate-to-vigorous physical activity (MVPA)
Time Frame: Baseline, 6 weeks, and 12 weeks
Moderate-to-vigorous physical activity (MVPA), assessed using a smartphone-based step counter application (Pacer), expressed as weekly minutes.
Change in self-reported physical activity level (IPAQ total score)
Time Frame: Baseline, 6 weeks, 12 weeks
Self-reported physical activity level will be assessed using the International Physical Activity Questionnaire (IPAQ). The primary outcome is the change in total physical activity level, expressed as MET-minutes per week, from baseline.
Secondary Outcomes
- Change in self-reported physical activity level (IPAQ total score)(Baseline, 6 weeks, 12 weeks)
- Change in walking capacity (6-Minute Walk Test distance)(Baseline, 6 weeks, 12 weeks)
- Change in physical function (SPPB total score)(Baseline, 6 weeks, 12 weeks)
- Change in walking impairment (WIQ total score)(Baseline, 6 weeks, 12 weeks)
- Change in quality of life (SF-12 PCS and MCS)(Baseline, 6 weeks, 12 weeks)
Investigators
Ayşe Adıgüzel Bayar
Physiotherapist
Muğla Sıtkı Koçman University