Peripheral Arterial DiseaseREVASC-PADNCT07223437
REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
A study testing Blood Flow Restriction Cuff System, Low-load Resistance Training and High-load Resistance Training in people with Peripheral Arterial Disease, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Blood Flow Restriction Cuff System, Low-load Resistance Training and High-load Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2026to 27 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosed peripheral arterial disease with stable claudication (symptomatic presentation unchanged for 6 months)
- Ankle-brachial index (ABI) between 0.4 and 0.9.
- Eligible referral to cardiovascular or pulmonary rehabilitation
- Prior revascularization permitted if symptoms are stable and other criteria are met
Who cannot join
- Recent change in resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 weeks), or another acute cardiac event
- Unstable angina
- Uncontrolled cardiac arrhythmias
- Symptomatic severe aortic stenosis or other significant valvular disease
- Decompensated symptomatic heart failure
- Acute pulmonary embolism or infarction
Show all 22Show fewer
- Acute noncardiac disorder likely to interfere with or be worsened by exercise (e.g., infection, thyrotoxicosis)
- Acute myocarditis or pericarditis
- Acute thrombophlebitis
- Physical disability precluding safe or adequate exercise performance
- Significant electrolyte abnormalities
- Clinically significant tachyarrhythmias or bradyarrhythmias
- High-degree atrioventricular block
- Atrial fibrillation with uncontrolled ventricular response
- Hypertrophic obstructive cardiomyopathy with resting left ventricular outflow gradient of >25 mmHg
- Known active aortic dissection
- Severe resting arterial hypertension (SBP>200mmHg or DBP >110 mmHg)
- Mental impairment preventing cooperation with study procedures
- Current pregnancy
- Moderate to severe peripheral neuropathy
- Open wounds or compromised skin near BFR cuff site
- Active DVT or thromboembolic event within the past year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Morgan Randall, MD
About this study
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:
- 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
- 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
- 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
- Conditions
- Peripheral Arterial Disease
- Being tested
- Blood Flow Restriction Cuff System, Low-load Resistance Training, High-load Resistance Training
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction Cuff SystemBehavioural
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 set of 30 repetitions, followed by 3 sets of 15 repetitions
- 30 seconds rest between sets, with the cuff remaining inflated
- Load set at 20-35% of 1RM
- Cuff deflated immediately after the fourth set or after 6 continuous minutes of inflation, whichever comes first
Low-load Resistance TrainingBehavioural
Two resistance exercises (seated and standing calf raises) using the same repetition structure
- 1 set of 30 repetitions, followed by 3 sets of 15 repetitions
- Load set at 20-35% of 1RM
- 30 seconds rest between sets
- No BFR cuffs will be used
High-load Resistance TrainingBehavioural
Each session includes:
- 3 sets of 8-12 repetitions
- Load set at 60-70% of 1RM
- Rest periods of 60-90 seconds between sets
- No BFR cuffs will be used
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Blood Flow Restriction Cuff System |
| 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. Receives: Behavioral: Low-load Resistance Training |
| 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. Receives: Behavioral: High-load Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)
Secondary outcomes (4)
Claudication Onset Time (COT) during 6MWT
Time to onset of claudication symptoms during 6MWT at baseline, post-intervention, and 3-month follow-up
Measured: Baseline, post-intervention (8 to 12 weeks), and 3 months post-intervention
Ratings of Perceived Exertion (RPE), Dyspnea, and Claudication Pain
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.
Measured: 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.
Measured: 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
Measured: Baseline to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start27 Apr 2026
- Primary completion27 Apr 2027 (estimated)
- Study completion27 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223437
- Sponsor's protocol ID
- 5460
- Other IDs
- Institutional Review Board
- Acronym
- REVASC-PAD
- Status last verified
- Oct 2025
- First submitted
- 24 Oct 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
- ClinicalTrials.gov ID
- NCT07223437
- Acronym / sponsor ID
- REVASC-PAD / 5460
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 27 Apr 2027 (estimated)
- Study completion
- 27 Apr 2027 (estimated)
- First posted
- 31 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction (BFR) Training | Experimental | Behavioral: Blood Flow Restriction Cuff SystemParticipants 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. |
| Low-Load Traditional Resistance Training (LL-RT) | Active comparator | Behavioral: Low-load Resistance TrainingParticipants 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. |
| High-Load Traditional Resistance Training (HL-RT) | Active comparator | Behavioral: High-load Resistance TrainingParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Diagnosed peripheral arterial disease with stable claudication (symptomatic presentation unchanged for 6 months)
- Ankle-brachial index (ABI) between 0.4 and 0.9.
- Eligible referral to cardiovascular or pulmonary rehabilitation
- Prior revascularization permitted if symptoms are stable and other criteria are met
Key exclusion criteria (22 listed)
- Recent change in resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 weeks), or another acute cardiac event
- Unstable angina
- Uncontrolled cardiac arrhythmias
- Symptomatic severe aortic stenosis or other significant valvular disease
- Decompensated symptomatic heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction Cuff SystemAll 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 | Behavioural | Blood Flow Restriction (BFR) Training |
| Low-load Resistance TrainingTwo 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 | Behavioural | Low-Load Traditional Resistance Training (LL-RT) |
| High-load Resistance TrainingEach 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 | Behavioural | High-Load Traditional Resistance Training (HL-RT) |
Primary outcome
Walking Function
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
4 secondary outcomes
Claudication Onset Time (COT) during 6MWT
Time frame: Baseline, post-intervention (8 to 12 weeks), and 3 months post-intervention
Ratings of Perceived Exertion (RPE), Dyspnea, and Claudication Pain
Time frame: Multiple assessments from Visit 2 through end of intervention (approximately 8 to 12 weeks)
Adverse Event (AE) and Serious Adverse Event (SAE) Rates
Time frame: Baseline to 3-month follow-up
Enrollment, Retention, and Adherence Rates
Time frame: Baseline to 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Cuff System, Low-load Resistance Training and High-load Resistance Training in people with Peripheral Arterial Disease, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Johnson, Study Coordinator (+1865-305-4682, thjohnson@utmck.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Function (time frame: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.