Home-Based Lower-Extremity Heat Therapy for Walking Function in Peripheral Artery Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorAquilo Sports, LLC

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Lower-Extremity Heat Therapy
  • Sham Lower-Extremity Heat Therapy

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Aquilo Sports, LLC

Lead sponsor

Indiana University

Collaborator

Purdue University

Collaborator