Peripheral Arterial Disease
Conditions
Brief summary
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: 1. Evaluate change in walking function among patients with PAD undergoing BFR training. The investigators will assess change in Six-Minute Walk Test (6MWT) distance from baseline to post-intervention and 3-month follow-up to compare functional improvements between the BFR group and the two control groups 2. Assess changes in health-related quality of life among patients with PAD undergoing BFR training. The investigators will use the EuroQol 5-Dimension 5-Level (EQ-5D-5L) scale to evaluate quality-of-life changes from baseline to post-intervention and 3-month follow-up across all study arms 3. Evaluate the safety and feasibility of a supervised BFR training program for patients with PAD. The investigators will compare adverse event (AE) and serious adverse event (SAE) rates across study arms, while also monitoring sessional ratings of perceived exertion (RPE), dyspnea, and claudication pain as indicators of symptom response and exercise tolerance. Feasibility will be assessed through enrollment success, intervention adherence, and retention rates across groups
Interventions
BEHAVIORALBlood Flow Restriction Cuff System
All BFR resistance sessions will include two standardized lower-extremity exercises: seated calf raises and standing calf raises. Each session will follow this protocol: 1. 1 set of 30 repetitions, followed by 3 sets of 15 repetitions 2. 30 seconds rest between sets, with the cuff remaining inflated 3. Load set at 20-35% of 1RM 4. Cuff deflated immediately after the fourth set or after 6 continuous minutes of inflation, whichever comes first
BEHAVIORALLow-load Resistance Training
Two resistance exercises (seated and standing calf raises) using the same repetition structure 1. 1 set of 30 repetitions, followed by 3 sets of 15 repetitions 2. Load set at 20-35% of 1RM 3. 30 seconds rest between sets 4. No BFR cuffs will be used
BEHAVIORALHigh-load Resistance Training
Each session includes: 1. 3 sets of 8-12 repetitions 2. Load set at 60-70% of 1RM 3. Rest periods of 60-90 seconds between sets 4. No BFR cuffs will be used
Sponsors
University of Tennessee Graduate School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Diagnosed peripheral arterial disease with stable claudication (symptomatic presentation unchanged for 6 months) 3. Ankle-brachial index (ABI) between 0.4 and 0.9. 4. Eligible referral to cardiovascular or pulmonary rehabilitation 5. Prior revascularization permitted if symptoms are stable and other criteria are met
Exclusion criteria
1. Recent change in resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 weeks), or another acute cardiac event 2. Unstable angina 3. Uncontrolled cardiac arrhythmias 4. Symptomatic severe aortic stenosis or other significant valvular disease 5. Decompensated symptomatic heart failure 6. Acute pulmonary embolism or infarction 7. Acute noncardiac disorder likely to interfere with or be worsened by exercise (e.g., infection, thyrotoxicosis) 8. Acute myocarditis or pericarditis 9. Acute thrombophlebitis 10. Physical disability precluding safe or adequate exercise performance 11. Significant electrolyte abnormalities 12. Clinically significant tachyarrhythmias or bradyarrhythmias 13. High-degree atrioventricular block 14. Atrial fibrillation with uncontrolled ventricular response 15. Hypertrophic obstructive cardiomyopathy with resting left ventricular outflow gradient of \>25 mmHg 16. Known active aortic dissection 17. Severe resting arterial hypertension (SBP\>200mmHg or DBP \>110 mmHg) 18. Mental impairment preventing cooperation with study procedures 19. Current pregnancy 20. Moderate to severe peripheral neuropathy 21. Open wounds or compromised skin near BFR cuff site 22. Active DVT or thromboembolic event within the past year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Function | Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF) | Change in walking distance measured by the Six-Minute Walk Test (6MWT) from baseline to end of intervention and 3-month follow-up visit. |
| Quality of Life (QoL) (1) | Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF) | 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 |
| Quality of Life (QoL) (2) | Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF) | Change in depressive symptoms as assessed by Patient Health Questionnaire-9 (PHQ-9) from baseline to post-intervention and 3-month follow-up |
| Quality of Life (QoL) (3) | Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Claudication Onset Time (COT) during 6MWT | Baseline, post-intervention (8 to 12 weeks), and 3 months post-intervention | Time to onset of claudication symptoms during 6MWT at baseline, post-intervention, and 3-month follow-up |
| Ratings of Perceived Exertion (RPE), Dyspnea, and Claudication Pain | Multiple assessments from Visit 2 through end of intervention (approximately 8 to 12 weeks) | 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. |
| Adverse Event (AE) and Serious Adverse Event (SAE) Rates | Baseline to 3-month follow-up | Number and rate of adverse events and serious adverse events occurring during the study period. |
| Enrollment, Retention, and Adherence Rates | Baseline to 3-month follow-up | Rates of successful enrollment, participant retention at post-intervention and 3-month follow-up, and adherence to prescribed exercise sessions |
Countries
United States
Contacts
CONTACTTiffany Johnson, Study Coordinator
Outcome results
None listed