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| ID | Type | Description | Link |
|---|---|---|---|
| Institutional Review Board | Other Identifier | The University of Tennessee Health Science Center |
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The purpose of this study is to evaluate the effects of Blood Flow Restriction (BFR) training on walking function, health-related quality of life, and safety among adults with Peripheral Arterial Disease (PAD).
The main aims of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Flow Restriction (BFR) Training | Experimental | Participants perform supervised lower-body resistance training using pneumatic cuffs (Smart Cuff Pro or equivalent) applied to the proximal thighs. Cuffs are inflated to 60-80% of the participant's measured arterial occlusion pressure (AOP). Pressure is increased at Weeks 5 and 9 based on tolerance. Cuff inflation will not exceed 80% of limb occlusion pressure. Cuffs will be immediately deflated if participants' vitals suggest poor tolerance. |
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| Low-Load Traditional Resistance Training (LL-RT) | Active Comparator | Participants perform the same two calf exercises (seated and standing calf raises) without BFR cuffs. If participants demonstrate the ability to complete all prescribed repetitions without undue strain, planned load progressions of approximately 5-10% 1RM will be introduced at Weeks 5 and 9. Repetitions and sets will remain fixed to match the BFR protocol. |
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| High-Load Traditional Resistance Training (HL-RT) | Active Comparator | Participants in this group will perform seated and standing calf raises following a more conventional strength training model. Similar to the other groups, if participants can complete their prescribed workload without excessive strain, two planned load progressions (5-10% 1RM) will be applied at Weeks 5 and 9. Repetitions and sets will remain fixed to preserve consistency in training structure across groups. This group serves as a benchmark for conventional resistance training in clinical and musculoskeletal rehabilitation populations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction Cuff System | Behavioral | All BFR resistance sessions will include two standardized lower-extremity exercises: seated calf raises and standing calf raises. Each session will follow this protocol:
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| Measure | Description | Time Frame |
|---|---|---|
| Walking Function | Change in walking distance measured by the Six-Minute Walk Test (6MWT) from baseline to end of intervention and 3-month follow-up visit. | Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF) |
| Quality of Life (QoL) (1) | Change in health-related quality of life as assessed by EuroQol 5-Dimension 5-Level (EQ-5D-5L) from baseline to post-intervention and 3-month follow-up | Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF) |
| Quality of Life (QoL) (2) | Change in depressive symptoms as assessed by Patient Health Questionnaire-9 (PHQ-9) from baseline to post-intervention and 3-month follow-up | Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF) |
| Quality of Life (QoL) (3) | Change in self-reported walking function and symptom burden assessed by using REVASC-PAD Walking Questionnaire from baseline to post-intervention and 3-month follow-up | Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF) |
| Measure | Description | Time Frame |
|---|---|---|
| Claudication Onset Time (COT) during 6MWT | Time to onset of claudication symptoms during 6MWT at baseline, post-intervention, and 3-month follow-up | Baseline, post-intervention (8 to 12 weeks), and 3 months post-intervention |
| Ratings of Perceived Exertion (RPE), Dyspnea, and Claudication Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Johnson, Study Coordinator | Contact | +1865-305-4682 | thjohnson@utmck.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Medical Center | Recruiting | Knoxville | Tennessee | 37920 | United States |
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| Low-load Resistance Training | Behavioral | Two resistance exercises (seated and standing calf raises) using the same repetition structure
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| High-load Resistance Training | Behavioral | Each session includes:
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Session-based self-reported symptom ratings collected at each supervised exercise session from Visit 2 to end of intervention (approximately 8 to 12 weeks). These ratings assess exercise tolerance and symptom burden during blood flow restriction training. |
| Multiple assessments from Visit 2 through end of intervention (approximately 8 to 12 weeks) |
| Adverse Event (AE) and Serious Adverse Event (SAE) Rates | Number and rate of adverse events and serious adverse events occurring during the study period. | Baseline to 3-month follow-up |
| Enrollment, Retention, and Adherence Rates | Rates of successful enrollment, participant retention at post-intervention and 3-month follow-up, and adherence to prescribed exercise sessions | Baseline to 3-month follow-up |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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