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Active, Not Recruiting

NCT Number: NCT07328646

BEHAVIOR CHANGE INTERVENTION AFTER ENDOVASCULAR REVASCULARIZATION IN PAD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aydın Özel Medinova Hastanesi

Efeler, Aydın, 09100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Supervised exercise program

Other

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

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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