BEHAVIOR CHANGE INTERVENTION AFTER ENDOVASCULAR REVASCULARIZATION IN PAD

NCT07328646 | Active Not Recruiting DMC

• 1 other identifier: Phd Thesis
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

BEHAVIOR CHANGE-BASED PHYSICAL ACTIVITY INTERVENTION IN PAD PATIENTS AFTER ENDOVASCULAR REVASCULARIZATION

Keywords

Peripheral Artery Disease; Endovascular Revascularization; Physical Activity; Exercise Therapy; Behavior Change; Walking Capacity; Physical Function; Sedentary Behavior; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in self-reported physical activity level (IPAQ total score)

  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.

  Baseline, 6 weeks, 12 weeks

Secondary Outcomes (4)

• 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

Study Arms (3)

Behavior Change Intervention Group

EXPERIMENTAL

Participants in this arm will receive a structured behavior change-based physical activity intervention following endovascular revascularization.

Behavioral: Behavior Change-Based Physical Activity Program

Supervised Exercise Group

ACTIVE COMPARATOR

Participants in this arm will receive a supervised exercise program following endovascular revascularization, without a structured behavior change component.

Other: Combined Behavior Change and Exercise Program

Combined Intervention Group

EXPERIMENTAL

Participants in this arm will receive a combined intervention including both a behavior change-based.

Other: Supervised Exercise Program

Interventions

Behavior Change-Based Physical Activity Program BEHAVIORAL

The program will include behavior change techniques such as goal setting, self-monitoring, action planning, motivational support, and education to promote physical activity and reduce sedentary time.

Behavior Change Intervention Group

Supervised Exercise Program OTHER

The supervised exercise program will consist of structured exercise sessions aimed at improving walking capacity and physical function.

Combined Intervention Group

Combined Behavior Change and Exercise Program OTHER

This intervention integrates behavior change techniques with supervised exercise to enhance physical activity adherence, walking capacity, physical function, and quality of life.

Supervised Exercise Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Aydın Özel Medinova Hastanesi

Efeler, Aydın, 09100, Turkey (Türkiye)

Location

Related Publications (1)

• Gardner AW, Montgomery PS, Wang M, Shen B. Minimal clinically important differences in daily physical activity outcomes following supervised and home-based exercise in peripheral artery disease. Vasc Med. 2022 Apr;27(2):142-149. doi: 10.1177/1358863X211072913. Epub 2022 Feb 15.

  PMID: 35164605 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 9, 2026
• Study Start: October 29, 2024
• Primary Completion: December 15, 2025
• Study Completion: February 27, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

TU (1)