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

June 12, 2026 updated by: Aquilo Sports, LLC

A Randomized, Sham-Controlled Trial of Home-Based Lower-Extremity Heat Therapy in Adults With Peripheral Artery Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Lower-extremity peripheral artery disease is associated with impaired walking ability, reduced lower-extremity function, exercise intolerance, and decreased quality of life. Reduced physical function in individuals with peripheral artery disease can limit daily activity and contribute to progressive mobility loss. This randomized, sham-controlled clinical trial will evaluate the effects of 12 weeks of home-based lower-extremity heat therapy on walking function, lower-extremity performance, blood pressure, and quality of life in adults with peripheral artery disease.

A total of 40 participants with peripheral artery disease will be enrolled and randomized to active lower-extremity heat therapy or sham therapy. Eligible participants will include men and women older than 45 years with a resting ankle-brachial index of less than 0.90 and greater than 0.40 in at least one leg. Participants will be excluded for conditions that may interfere with safe participation or outcome assessment, including critical limb ischemia, ischemic rest pain, ischemia-related non-healing wounds or tissue loss, prior amputation, major exercise-limiting comorbidity, recent lower-extremity revascularization or orthopedic surgery, use of a walking aid other than a cane, active treatment for cancer, severe chronic kidney disease, class 2 or 3 obesity, or inability to use the study treatment system as intended.

Participants will complete baseline study visits that include informed consent, resting ankle-brachial index measurement, familiarization with study procedures, and baseline assessment of walking function and lower-extremity performance. Baseline outcome measures will include the six-minute walk test, assessment of calf strength and fatigability using isokinetic dynamometry, the Short Physical Performance Battery, and blood pressure measurement.

After completion of baseline assessments, participants will be randomized to one of two study groups using a blocked randomization scheme stratified by sex. Participants assigned to the active therapy group will complete daily 90-minute home-based lower-extremity heat therapy sessions for 12 weeks. Participants assigned to the sham therapy group will complete the same treatment schedule using a lower-temperature sham condition designed to preserve participant blinding while minimizing the expected physiological effects of active heat therapy.

Outcome assessments will be repeated at week 6 and week 12. To evaluate chronic rather than acute responses to treatment, participants will be instructed to interrupt therapy 48 hours before follow-up outcome visits. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Raghu Motaganahalli, MD
  • Phone Number: 317-962-2300
  • Email: rmotagan@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Methodist Hospital
        • Contact:
          • Raghu Motaganahalli, MD
          • Phone Number: 317-962-2300
          • Email: rmotagan@iu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Lower-Extremity Heat Therapy
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 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.
Device: Sham Lower-Extremity Heat Therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6-minute walk distance
Time Frame: 12 weeks
Participants will receive standardized instructions and will be asked to walk the greatest distance possible by walking back and forth along a 100-ft corridor for 6 min. The primary outcome will be a change from baseline in the 6-minute walk distance over 12 weeks in the HT-treated group as compared to the sham treatment group.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peak plantar flexor and knee extensor power
Time Frame: 12 weeks
Torque assessments of the plantar flexors and knee extensors of the most symptomatic leg or the leg with the lowest ABI will be performed using an isokinetic dynamometer. Each subject will be asked to perform 3 maximal contractions at angular velocities of 0, 1.57, 3.14, 4.71, and 6.28 rad/sec, with 2 min of rest between each set. Peak power will be calculated by multiplying the peak torque observed at each velocity by that velocity. A parabolic function will be used to determine the subject's maximal plantar flexor velocity (Vmax) and maximal power (P max). The change in peak power from baseline to 12 weeks will be compared between the HT-treated group and the sham treatment group.
12 weeks
Plantar flexor and knee extensor resistance to fatigue
Time Frame: 12 weeks
Participants will perform 50 consecutive maximal contractions of the plantar flexor and knee extensor muscles at an angular velocity of 3.14 rad/sec to determine their resistance to fatigue. The fatigue index will be defined as a % decrease in power from first 1/3 to last 1/3 of the test) during repeated contractions. The change in fatigue resistance from baseline to 12 weeks will be compared between the HT-treated group and the sham treatment group.
12 weeks
Short Physical Performance Battery (SPPB) score
Time Frame: 12 weeks
The SPPB combines data from the usual paced 4-m walking velocity, time to rise from a seated position 5 times, and standing balance. The timed results of the subtests will be converted to an ordinal scale ranging from 0 (worst performance) to 12 (best performance) (1). The change in the SPPB score from baseline to 12 weeks will be compared between the HT-treated group and the sham treatment group.
12 weeks
Walking Impairment Questionnaire (WIQ)
Time Frame: 12 weeks
This disease-specific questionnaire assesses the ability of patients with PAD to walk defined distances and speeds and to climb stairs, with scores ranging from 0 to 100. The change in the WIQ score from baseline to 12 weeks will be compared between the HT-treated group and the sham treatment group.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aquilo Sports, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Indiana University
Purdue University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raghu Motaganahalli, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AQUILO-LEHT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan for sharing de-identified individual participant data has not yet been finalized. Any future data sharing will be determined after review of the final protocol, informed consent language, institutional requirements, sponsor requirements, participant privacy protections, and applicable regulatory and funding requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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