Blood Flow Restriction for Peripheral Arterial Disease

(REVASC-PAD Trial)

Overseen By Tiffany Johnson, Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Tennessee Graduate School of Medicine

Disqualifiers: Unstable angina, Heart failure, Hypertension, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how Blood Flow Restriction (BFR) training can improve walking ability and quality of life for individuals with Peripheral Arterial Disease (PAD). Researchers aim to determine if BFR training, which uses a Blood Flow Restriction Cuff System, is safe and effective compared to other exercise methods without BFR. It suits those who have experienced stable leg pain when walking due to PAD for at least six months. Participants will engage in monitored exercise sessions to assess changes in walking performance and overall well-being. As an unphased trial, this study allows participants to contribute to innovative research that could enhance treatment options for PAD.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Blood Flow Restriction training is safe for patients with Peripheral Arterial Disease?

Research has shown that blood flow restriction (BFR) training is generally safe. In one study, participants adhered well to the training, experiencing few negative effects. Another study found that serious side effects, such as muscle breakdown (rhabdomyolysis) and fainting, were rare, occurring in 1.9% and 3.8% of cases, respectively. While some risks exist, they are uncommon. Overall, most individuals tolerate BFR training well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Blood Flow Restriction (BFR) Training technique for Peripheral Arterial Disease (PAD) because it offers a unique approach compared to traditional exercise regimens. Unlike standard treatments that typically involve high-load resistance exercises, BFR Training uses pneumatic cuffs to limit blood flow to the muscles during low-load exercises. This method can potentially enhance muscle strength and function without the need for heavy weights, which may be beneficial for PAD patients who struggle with intense physical activity. Additionally, by gradually adjusting the cuff pressure based on individual tolerance, this technique could provide a personalized and safer exercise option.

What evidence suggests that Blood Flow Restriction training is effective for Peripheral Arterial Disease?

Research has shown that Blood Flow Restriction (BFR) training, which participants in this trial may receive, can improve muscle strength and endurance in people with Peripheral Arterial Disease (PAD). One study found that 86% of patients using BFR improved their walking ability, compared to 46% in a group that did not use BFR. BFR training also increases muscle strength and reduces tiredness, potentially helping people become more active. This method involves performing light exercises while limiting blood flow, which has been shown to enhance heart and blood vessel health. Overall, BFR appears promising for those seeking to improve walking ability and quality of life with PAD. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Adults with Peripheral Arterial Disease (PAD) who have stable claudication and an Ankle-brachial index (ABI) between 0.4 and 0.9 can join this study. They must be over 18, referred for cardiovascular or pulmonary rehab, and may have had prior revascularization if stable. Excluded are those with mental impairments, recent heart issues, severe hypertension, uncontrolled arrhythmias, significant valvular disease, active blood clots or infections.

Inclusion Criteria

Ankle-brachial index (ABI) between 0.4 and 0.9

I am 18 years old or older.

I have stable leg pain from peripheral artery disease for 6 months.

Exclusion Criteria

Mental impairment preventing cooperation with study procedures

Current pregnancy

Significant electrolyte abnormalities

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Blood Flow Restriction (BFR) training or traditional resistance training for 8 to 12 weeks

8-12 weeks

Multiple supervised exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 3-month follow-up assessment

3 months

3-month follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• Blood Flow Restriction Cuff System

Trial Overview The REVASC-PAD trial is testing the effects of Blood Flow Restriction (BFR) training on walking function and quality of life in PAD patients compared to low-load and high-load resistance training groups. It measures changes in a six-minute walk test and health-related quality of life scales before/after intervention and at a three-month follow-up.

How Is the Trial Designed?

Group I: Blood Flow Restriction (BFR) Training Experimental Treatment 1 Intervention

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.

Group II: Low-Load Traditional Resistance Training (LL-RT) Active Control 1 Intervention

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.

Group III: High-Load Traditional Resistance Training (HL-RT) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Tennessee Graduate School of Medicine

Lead Sponsor

Trials

17

Recruited

1,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10205295/

Blood flow restricted walking in patients suffering from ... BFR-W is feasible and appears to be safe in terms of completion rate, adherence to the training protocol, and adverse events in patients with IC.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04890275

Blood Flow Restricted Resistance Training in Peripheral ... The primary aim of this study is to determine the feasibility of 12 weeks of lower body resistance exercise performed with blood flow restriction (BFR) in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1440244025004724

Blood flow restriction training improves strength, fatigue ... The results showed significant improvements in perceived disease impact, muscle strength, fatigue, physical activity levels, and manual ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10233322/

The effectiveness of blood flow restriction training in ... Current evidence suggests that BFR combined with low-load exercises can improve muscle strength, cardiovascular endurance, and functionality in patients with ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/1358863X231200250

Low-intensity resistance exercise with blood flow restriction ... Clinical improvement in walking was achieved in 86% of patients in the BFR group but in only 46% of patients in the control group. Time to claudication pain ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07223437

Study Details | NCT07223437 | REVASC-PAD: REstricted ... The purpose of this study is to evaluate the effects of Blood Flow Restriction (BFR) training on walking function, health-related quality of life, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10693738/

Low-intensity resistance exercise with blood flow restriction for ... All success criteria of the feasibility trial were met. Exercise adherence was high (BFR = 78.3%, control = 83.8%), loss to follow up was 10%, and there were no ...

8. academic.oup.com academic.oup.com/milmed/article/187/9-10/1059/6548011

Overall Safety and Risks Associated with Blood Flow ... The incidence of rhabdomyolysis and fainting were reported to be 1.9% and 3.8%, respectively.23 In the other study surveying 250 exercise/ ...