Home-based Leg Heat Therapy (HHT)

Home-based Leg Heat Therapy for Patients With Symptomatic Peripheral Arterial Disease

The objective of this study is to evaluate the benefits of participating for 8 weeks in a home-based daily treatment with heat therapy (HT) or a thermoneutral control intervention, as assessed by vascular function, walking tolerance and quality of life.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Control/Sham Treatment; Device: Heat Therapy

Detailed Description

Heat therapy (HT) is an emerging non-invasive approach that has been shown to enhance vascular function of the leg in old individuals. The objective of this randomized, controlled study is to evaluate the benefits of participating for 8 weeks in a home-based daily treatment with heat therapy (HT) or a thermoneutral control intervention, as assessed by vascular function, walking tolerance and quality of life. The central hypothesis of this study, based on preliminary data, is that exposure to HT will enhance the oxygenation of calf muscles during exercise and as a result, the onset of pain will be delayed and walking performance will be enhanced. The duration (8 weeks) was chosen based on the recent report of Brunt and co-workers that the improvement in endothelial function promoted by repeat HT in sedentary individuals peaks at 8 weeks following the onset of treatment. Heat Therapy will be applied daily for 90 minutes using water-circulating 'pants' connected to a water pump. Outcomes will be assessed at the halfway point (end of week 4), at the completion of the intervention (end of week 8) and 4 weeks after the end of the intervention (week 12).

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Heath Methodist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women with a stable symptomatic PAD for ≥6 months
• Ankle brachial index <0.9 in at least one leg
• Age between 40 and 80 years

Exclusion Criteria:

• Uncontrolled Diabetes (HbA1C > 8.5 measured within 3 months prior to date of consent)
• Wheelchair bound
• Use of a walking aid (i.e. cane, crutches, walker, motorized chair)
• Critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or tissue loss
• Impaired thermal sensation in the legs
• Exercise-limiting comorbidity
• Chronic Heart Failure stages C and stage D (Stage C: structural heart disease is present and symptoms have occurred; Stage D: presence of advanced heart disease with continued heart failure symptoms requiring aggressive medical therapy)
• Morbid obesity BMI > 35 or unable to fit into water-circulating pants
• Open wounds or ulcers on the extremity
• Prior amputation
• Lower extremity revascularization, major orthopedic surgery, cardiovascular event, or coronary revascularization in the previous three months
• Planned revascularization or major surgery during the next six months
• Plans to change medical therapy during the duration of the study
• Active treatment for cancer
• Chronic kidney disease (eGFR <30 by MDRD or Mayo or Cockcroft-Gault formula).
• HIV positive, active HBV or HCV disease.
• Presence of any clinical condition that makes the patient not suitable to participate in the trial.
• Unable to walk on the treadmill

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham treatment; Participants were dressed in water-circulating trousers that are connected to a pump. Water at 91.4 degrees F was circulated through the pants for 90 minutes daily for 8 weeks..	Device: Control/Sham Treatment; Thermoneutral water will be circulated through water-circulating trousers to maintain skin temperature at baselines levels daily for 90 minutes for 8 weeks.
Active Comparator: Heat Therapy; Participants were dressed in water-circulating trousers that are connected to a pump. Water at 110 degrees F will be circulated through the pants for 90 minutes daily for 8 weeks.	Device: Heat Therapy; Water at 110 degrees F will be circulated through water-circulating trousers daily for 90 minutes for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6-min Walk Distance	Change in 6-min walk distance from baseline to the 8-week follow-up	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Treadmill Peak Walking Time	Change in treadmill peak walking time from baseline to 8-week follow-up	8 weeks
Change in Peak Calf Blood Flow	Change in peak calf blood flow during reactive hyperemia from baseline to the 8-week follow-up	8 weeks
Change in Leg Cutaneous Vascular Conductance	Change in cutaneous vascular conductance from baseline to the 8-week follow-up	8 weeks
Change in the Vascular Quality of Life Questionnaire-6 Score	Change in Vascular Quality of Life Questionnaire-6 score from baseline to the 8-week follow-up. The total VASCUQOL score is the average score of questions answered and ranges from 1 (worst QOL) to 7 (best QOL)	8 weeks
Change in the Short Form 36 Physical Functioning Score	Change in the physical functioning subscale score from baseline to the 8-week follow-up. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. A high score defines a more favorable health state.	8 weeks

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Roseguini, Bruno, PhD
• Investigators: Principal Investigator: R Motaganahalli, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): June 21, 2021
• Study Completion (Actual): June 21, 2021

Study Registration Dates

• First Submitted: November 23, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 1801755556

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes