search
Back to results

Home-based Leg Heat Therapy (HHT)

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control/Sham Treatment
Heat Therapy
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IU Heath Methodist

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham treatment

Heat Therapy

Arm Description

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..

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.

Outcomes

Primary Outcome Measures

Change in 6-min Walk Distance
Change in 6-min walk distance from baseline to the 8-week follow-up

Secondary Outcome Measures

Change in Treadmill Peak Walking Time
Change in treadmill peak walking time from baseline to 8-week follow-up
Change in Peak Calf Blood Flow
Change in peak calf blood flow during reactive hyperemia from baseline to the 8-week follow-up
Change in Leg Cutaneous Vascular Conductance
Change in cutaneous vascular conductance from baseline to the 8-week follow-up
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)
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.

Full Information

First Posted
November 23, 2018
Last Updated
February 27, 2023
Sponsor
Indiana University
Collaborators
Roseguini, Bruno, PhD
search

1. Study Identification

Unique Protocol Identification Number
NCT03763331
Brief Title
Home-based Leg Heat Therapy
Acronym
HHT
Official Title
Home-based Leg Heat Therapy for Patients With Symptomatic Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Roseguini, Bruno, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were randomized (blocked and stratified by sex) using assignments generated from PROC PLAN in SAS Version 9.4 by the study statistician into one of two groups: those receiving leg heat therapy or those receiving the sham treatment.
Masking
Participant
Masking Description
Participants were informed that there were two different categories of heat therapy, "low heat" and "high heat," and that both might be beneficial for claudication symptoms.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
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..
Arm Title
Heat Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Control/Sham Treatment
Intervention Description
Thermoneutral water will be circulated through water-circulating trousers to maintain skin temperature at baselines levels daily for 90 minutes for 8 weeks.
Intervention Type
Device
Intervention Name(s)
Heat Therapy
Intervention Description
Water at 110 degrees F will be circulated through water-circulating trousers daily for 90 minutes for 8 weeks.
Primary Outcome Measure Information:
Title
Change in 6-min Walk Distance
Description
Change in 6-min walk distance from baseline to the 8-week follow-up
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Treadmill Peak Walking Time
Description
Change in treadmill peak walking time from baseline to 8-week follow-up
Time Frame
8 weeks
Title
Change in Peak Calf Blood Flow
Description
Change in peak calf blood flow during reactive hyperemia from baseline to the 8-week follow-up
Time Frame
8 weeks
Title
Change in Leg Cutaneous Vascular Conductance
Description
Change in cutaneous vascular conductance from baseline to the 8-week follow-up
Time Frame
8 weeks
Title
Change in the Vascular Quality of Life Questionnaire-6 Score
Description
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)
Time Frame
8 weeks
Title
Change in the Short Form 36 Physical Functioning Score
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R Motaganahalli
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Heath Methodist
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Home-based Leg Heat Therapy

We'll reach out to this number within 24 hrs