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

Conditions

• PAD
• PAD - Peripheral Arterial Disease

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lower-Extremity Heat Therapy — 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 — 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

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.

Key Dates

Start date

Jan 1, 2027

Status verified

Jun 2026

Primary completion

Mar 30, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Active Lower-Extremity Heat Therapy
  Participants assigned to this arm will complete home-based lower-extremity heat therapy sessions for 90 minutes per day for 12 weeks. The active therapy condition will use heated lower-extremity garments according to the study protocol.
• Sham Comparator: Sham Lower-Extremity Heat Therapy
  Participants assigned to this arm will complete sham home-based lower-extremity therapy sessions for 90 minutes per day for 12 weeks. The sham condition will use the same treatment schedule and similar lower-extremity garments, with a lower-temperature condition designed to preserve participant blinding while minimizing the expected physiological effects of active heat therapy.

Primary Outcome Measure

6-minute walk distance [ Time Frame: 12 weeks ]

Central Contacts

• Raghu Motaganahalli, MD
  317-962-2300
  [email protected]

Locations (1)

Find similar trials in Indianapolis, IN

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