What this study is
Lower-extremity peripheral artery disease is associated with impaired walking ability, reduced lower-extremity function, and decreased quality of life. This randomized, sham-controlled clinical trial will evaluate the effects of 12 weeks of home-based lower-extremity heat therapy on walking function and mobility in adults with peripheral artery disease.
A total of 40 participants will be randomized to active lower-extremity heat therapy or sham therapy. Participants assigned to active therapy will complete daily 90-minute home treatment sessions using heated lower-extremity garments. Participants assigned to sham therapy will complete the same treatment schedule using a lower-temperature sham condition.
The primary outcome is the change in six-minute walk distance from baseline to 12 weeks. Secondary outcomes include changes in leg strength and fatigability, Short Physical Performance Battery score, blood pressure, and patient-reported quality of life.
What's being tested
- Lower-Extremity Heat Therapy
Intervention · DEVICE
Participants assigned to the active intervention will complete home-based lower-extremity heat therapy sessions for 90 minutes per day for 12 weeks. The active condition will deliver heated therapy to the lower extremities according to the study protocol.
- Sham Lower-Extremity Heat Therapy
Intervention · DEVICE
Participants assigned to the sham comparator will complete home-based sham therapy sessions for 90 minutes per day for 12 weeks. The sham condition will use the same treatment schedule and similar lower-extremity garments as the active condition, but will use a lower-temperature condition intended to support participant blinding while minimizing the expected physiological effects of active heat therapy.
Study details
- Official title
- A Randomized, Sham-Controlled Trial of Home-Based Lower-Extremity Heat Therapy in Adults With Peripheral Artery Disease
- Sponsor
- Aquilo Sports, LLC
- Conditions
- PAD · PAD - Peripheral Arterial Disease
- Enrolling
- 40 people
- Starts
- 2027-01-01
- Est. completion
- 2029-06-30
- Design
- Quadruple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 50 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Men and women older than 50 years of age
- Resting ankle-brachial index (ABI) of <0.9 but >0.4 in at least one leg
You can't join if
- Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss
- Prior amputation
- Exercise-limiting comorbidity
- Recent (<3 months) lower-extremity revascularization or orthopedic surgery
- Use of walking aid other than a cane
- Active treatment for cancer
- Chronic kidney disease (eGFR <30 by MDRD or Mayo or Cockcroft-Gault formula)
- Class 2 or 3 obesity (BMI ≥ 35 kg/m2)
- Unable to fit into water-circulating trousers
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMethodist Hospital
Indianapolis, Indiana, United States
- Raghu Motaganahalli, MD · Contact317-962-2300rmotagan@iu.edu
Study team
Sponsor
Aquilo Sports, LLC
Study ID AQUILO-LEHT-001
Principal investigator
Raghu Motaganahalli, MD
Indiana University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.