BEHAVIOR CHANGE INTERVENTION AFTER ENDOVASCULAR REVASCULARIZATION IN PAD

NCT ID: NCT07328646

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-29

Study Completion Date

2026-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Behavior Change Intervention Group

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

Group Type EXPERIMENTAL

Behavior Change-Based Physical Activity Program

Intervention Type 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.

Supervised Exercise Group

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

Group Type ACTIVE_COMPARATOR

Combined Behavior Change and Exercise Program

Intervention Type OTHER

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

Combined Intervention Group

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

Group Type EXPERIMENTAL

Supervised Exercise Program

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

Supervised Exercise Program

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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Ayşe Adıgüzel Bayar

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aydın Özel Medinova Hastanesi

Efeler, Aydın, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 35164605 (View on PubMed)

Other Identifiers

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Phd Thesis

Identifier Type: -

Identifier Source: org_study_id

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