BEHAVIOR CHANGE INTERVENTION AFTER ENDOVASCULAR REVASCULARIZATION IN PAD

December 27, 2025 updated by: Ayşe Adıgüzel Bayar, Muğla Sıtkı Koçman University

EFFECTIVENESS OF A BEHAVIOR CHANGE INTERVENTION AIMED AT INCREASING PHYSICAL ACTIVITY IN PATIENTS WITH PERIPHERAL ARTERY DISEASE UNDERGOING ENDOVASCULAR REVASCULARIZATION

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Aydın
      • Efeler, Aydın, Turkey (Türkiye), 09100
        • Aydın Özel Medinova Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavior Change Intervention Group
Participants in this arm will receive a structured behavior change-based physical activity intervention following endovascular revascularization.
Behavioral: Behavior Change-Based Physical Activity Program
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.
Active Comparator: Supervised Exercise Group
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
This intervention integrates behavior change techniques with supervised exercise to enhance physical activity adherence, walking capacity, physical function, and quality of life.
Experimental: Combined Intervention Group
Participants in this arm will receive a combined intervention including both a behavior change-based.
Other: Supervised Exercise Program
The supervised exercise program will consist of structured exercise sessions aimed at improving walking capacity and physical function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in walking capacity (6-Minute Walk Test distance)
Time Frame: Baseline, 6 weeks, 12 weeks
Walking capacity will be assessed using the 6-Minute Walk Test. The primary endpoint is the change in 6MWT distance (meters) from baseline.
Baseline, 6 weeks, 12 weeks
Change in physical function (SPPB total score)
Time Frame: Baseline, 6 weeks, 12 weeks
Physical function will be evaluated using the Short Physical Performance Battery (SPPB). The outcome is the change in SPPB total score from baseline.
Baseline, 6 weeks, 12 weeks
Change in walking impairment (WIQ total score)
Time Frame: Baseline, 6 weeks, 12 weeks
Walking impairment will be evaluated using the Walking Impairment Questionnaire (WIQ). The outcome is change in WIQ total score from baseline.
Baseline, 6 weeks, 12 weeks
Change in quality of life (SF-12 PCS and MCS)
Time Frame: Baseline, 6 weeks, 12 weeks
Quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12). Outcomes include changes in Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.
Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muğla Sıtkı Koçman University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2024

Primary Completion (Actual)

December 15, 2025

Study Completion (Estimated)

February 27, 2026

Study Registration Dates

First Submitted

December 27, 2025

First Submitted That Met QC Criteria

December 27, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 27, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhD Thesis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data will not be shared due to ethical and privacy considerations, as well as the absence of explicit participant consent for data sharing. The study involves a relatively small sample size, which may increase the risk of participant re-identification. Data will be reported only in aggregate form in scientific publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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