Can light exercise with blood flow cuffs help PAD patients walk better?
NCT ID NCT07223437
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a special exercise program using blood flow restriction cuffs can improve walking ability and quality of life in people with peripheral arterial disease (PAD). About 81 adults with stable leg pain from PAD will do low-intensity calf raises while wearing cuffs that limit blood flow. Researchers will measure walking distance, symptoms, and safety over 3 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Blood Flow Restriction Cuff System
- What this could lead to
- If it works, this could offer a new, low-intensity exercise option to help people with PAD walk farther and feel better.
- What could go wrong
- This is a small feasibility study, so results may not apply broadly. The exercise involves temporary blood flow restriction, which may cause discomfort or leg pain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 81 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2026
- Expected to finish
-
Apr 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Peripheral arterial disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of Tennessee Medical Center
RECRUITINGKnoxville, Tennessee, 37920, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Smartwatch-Coached walking at home put to the test for leg artery disease
- Could pressing instead of plugging let patients walk sooner after leg artery procedures?
- Which artery plug works best? trial pits proglide against femoseal
- Can artery clearing for blocked legs be done without an overnight stay?
- AI plus ultrasound could catch heart and lung decline before it turns critical
- A window into living tissue: new sensor may spot dangerous oxygen drops during surgery