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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 AyÅŸe ADIGÃœZEL 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavior Change Intervention Group | Experimental | Participants in this arm will receive a structured behavior change-based physical activity intervention following endovascular revascularization. |
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| Supervised Exercise Group | Active Comparator | Participants in this arm will receive a supervised exercise program following endovascular revascularization, without a structured behavior change component. |
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| Combined Intervention Group | Experimental | Participants in this arm will receive a combined intervention including both a behavior change-based. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in walking capacity (6-Minute Walk Test distance) | 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) |
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Inclusion Criteria:
Aged between 50 and 80 years
Able to read, understand, and write Turkish
Scheduled to undergo endovascular revascularization for peripheral artery disease
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aydın Özel Medinova Hastanesi | Efeler | Aydın | 09100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35164605 | Background | 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. |
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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.
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| Supervised Exercise Program | Other | The supervised exercise program will consist of structured exercise sessions aimed at improving walking capacity and physical function. |
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| 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. |
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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) | 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) | 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 |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D009043 | Motor Activity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D001519 | Behavior |
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