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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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