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Leg Heat Therapy in Peripheral Artery Disease

Primary Purpose

Peripheral Artery Disease

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Leg heat therapy
Sham Control
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring heat therapy, peripheral artery disease, walking performance, muscle strength

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women older than 60 years
  • Resting ankle-brachial index (ABI) of 0.9 or less in at least one leg. Individuals with a resting ABI between 0.91 and 1.00 at baseline will be eligible if their ABI drops by 20% or greater following a heel-rise test.

Exclusion Criteria:

  • Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss)
  • Prior foot or leg amputation
  • Exercise tolerance limited by factors other than leg pain (e.g. angina, arthritis, severe lung disease, etc).
  • Recent (<3 months) lower-extremity revascularization or orthopedic surgery
  • Use of walking aid other than a cane
  • Active 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
  • A Mini-Mental Status Examination score <23
  • Impaired thermal sensation in the leg

As this study involves MR imaging, patients that have contraindications to MRI will be included in the study but will not be allowed to participate in the MRI experiment. Information about biomedical devices that may pose a risk to patients undergoing MRI is available on the Internet at www.MRIsafety.com. These exclusions include: cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, cochlear, otologic, or ear implant and history of claustrophobia or who are unable to lie flat or who do not fit inside the bore of the scanner.

Sites / Locations

  • Indiana University Health Methodist HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Heat therapy

Sham Control

Arm Description

Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 42ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.

Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 33ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.

Outcomes

Primary Outcome Measures

Change in 6-minute walk distance
The investigators will determine whether daily leg heat therapy for 90 min using water-circulating trousers perfused with water heated to 42ºC improves the 6-minute walk distance at 3-month follow-up compared to a sham treatment.

Secondary Outcome Measures

Change in Walking Impairment Questionnaire (WIQ) score
This disease-specific questionnaire assess the ability of patients with PAD to walk defined distances and speeds and to climb stairs, with scores ranging from 0 to 100. Higher scores are reflective of better community-based walking ability. The investigators will determine whether leg heat therapy improves the WIQ score at 3-month follow-up compared to the sham treatment.
Change in Short-Form (SF)-36 Questionnaire score
Health-related quality of life (HRQOL) will be assessed using the short-form SF-36 questionnaire, which is composed of 8 subscales. Each subscale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. The investigators will determine whether leg heat therapy improves the SF-36 score at 3-month follow-up compared to the sham treatment.
Change in Short Physical Performance Battery (SPPB) score
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). The investigators will determine whether leg heat therapy improves the SPPB score at 3-month follow-up compared to the sham treatment.
Change in handgrip strength
The assessment of maximal handgrip strength will be will performed using a hand dynamometer. The investigators will determine whether leg heat therapy improves handgrip strength at 3-month follow-up compared to the sham treatment.
Change in systolic blood pressure
The systolic blood pressure will be measured in triplicate using a blood pressure monitor. The investigators will determine whether leg heat therapy improves systolic blood pressure at 3-month follow-up compared to the sham treatment.
Change in diastolic blood pressure
The diastolic blood pressure will be measured in triplicate using a blood pressure monitor. The investigators will determine whether leg heat therapy improves blood pressure at 3-month follow-up compared to the sham treatment.
Change in triceps surae volume
The volume of calf muscles will be determined using magnetic resonance (MR) images. The investigators will determine whether leg heat therapy improves calf muscle volume at 3-month follow-up compared to the sham treatment.
Change in triceps surae intramuscular fat content
The intramuscular fat content of calf muscles will be determined using magnetic resonance (MR) images. The investigators will determine whether leg heat therapy reduces intramuscular fat content at 3-month follow-up compared to the sham treatment.
Change in the time constant for phosphocreatine recovery after dynamic exercise
Magnetic resonance spectroscopy tuned to phosphorous (31PMRS) will be used to measure the time constant for PCr recovery (τ) after dynamic planar flexion exercise. The investigators will determine whether leg heat therapy reduces the time constant for PCr recovery at 3-month follow-up compared to the sham treatment.
Change in maximal plantar flexor strength
The maximal voluntary contraction (MVC) strength of the plantar flexor muscles will be assessed using an MR-compatible ergometer (Trispect, Ergospect GmbH, Innsbruck, Austria), Participants will be asked to perform three 4-5 s plantar-flexor MVCs separated by a one-minute rest period. The MVC torque will be considered the highest peak torque value measured over the three trials.

Full Information

First Posted
July 14, 2022
Last Updated
April 29, 2023
Sponsor
Indiana University
Collaborators
Purdue University, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05465070
Brief Title
Leg Heat Therapy in Peripheral Artery Disease
Official Title
Leg Heat Therapy to Improve Functional Performance in Peripheral Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Purdue University, National Institute on Aging (NIA)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this randomized, double-blind, sham-controlled clinical trial is to evaluate the benefits of home-based, leg heat therapy (HT) on lower-extremity functioning and quality of life in patients who suffer from lower-extremity peripheral artery disease (PAD). We will randomize 106 patients to one of two groups that either receive leg HT or a sham intervention. The primary study outcome is the change in 6-minute walk distance between baseline and the 12-week follow up. Secondary outcomes include changes in the short physical performance battery score, handgrip strength, quality of life (measured by the Walking Impairment Questionnaire and Short-Form (SF)-36 Questionnaire), calf muscle strength (measured using a calf ergometer), size (measured by magnetic resonance imaging) and bioenergetics (assessed using phosphorus-31 magnetic resonance spectroscopy), and physical activity (measured by accelerometer).
Detailed Description
The lack of accessible therapies amenable for application in the home setting is a major obstacle for treating patients who suffer from lower-extremity peripheral artery disease (PAD). The investigators will determine whether unsupervised, home-based leg heat therapy (HT) improves walking performance compared to a sham intervention. Leg HT will be applied using water-circulating trousers coupled with a water pump and a water heater. Patients will be randomized into one of two groups: those receiving HT (n=53) or those receiving a sham treatment (n=53).The water heater and pump given to participants in the HT group will be adjusted to circulate water at 42ºC through the trousers. In the sham group, water at 33ºC will be circulated through the trousers. Participants will be asked to apply the therapy daily for 90 min for 3 consecutive months. Outcomes will be assessed at baseline, at the completion of the intervention (end of week 12) and at a follow-up visit, 12 weeks after the end of the intervention (week 24). The primary study outcome is the change in 6-minute walk distance between baseline and the 12-week follow up. Secondary outcomes include changes in the short physical performance battery score, which combines performance in walking speed, standing balance, and repeated chair rises, changes in handgrip strength, perceived quality of life (measured by the Walking Impairment Questionnaire and Short-Form (SF)-36 Questionnaire), calf muscle strength (measured using a calf ergometer), size (measured by magnetic resonance imaging) and bioenergetics (assessed using phosphorus-31 magnetic resonance spectroscopy), and physical activity (measured by accelerometer).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
heat therapy, peripheral artery disease, walking performance, muscle strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heat therapy
Arm Type
Experimental
Arm Description
Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 42ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.
Arm Title
Sham Control
Arm Type
Active Comparator
Arm Description
Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 33ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.
Intervention Type
Device
Intervention Name(s)
Leg heat therapy
Intervention Description
A sous vide heating immersion circulator heats up the water inside the water tank to 42ºC. A water pump circulates temperature-regulated water through the trousers.
Intervention Type
Device
Intervention Name(s)
Sham Control
Intervention Description
A sous vide heating immersion circulator heats up the water inside the water tank to 33ºC. A water pump circulates temperature-regulated water through the trousers.
Primary Outcome Measure Information:
Title
Change in 6-minute walk distance
Description
The investigators will determine whether daily leg heat therapy for 90 min using water-circulating trousers perfused with water heated to 42ºC improves the 6-minute walk distance at 3-month follow-up compared to a sham treatment.
Time Frame
Baseline to 3-month follow-up
Secondary Outcome Measure Information:
Title
Change in Walking Impairment Questionnaire (WIQ) score
Description
This disease-specific questionnaire assess the ability of patients with PAD to walk defined distances and speeds and to climb stairs, with scores ranging from 0 to 100. Higher scores are reflective of better community-based walking ability. The investigators will determine whether leg heat therapy improves the WIQ score at 3-month follow-up compared to the sham treatment.
Time Frame
Baseline to 3-month follow-up
Title
Change in Short-Form (SF)-36 Questionnaire score
Description
Health-related quality of life (HRQOL) will be assessed using the short-form SF-36 questionnaire, which is composed of 8 subscales. Each subscale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. The investigators will determine whether leg heat therapy improves the SF-36 score at 3-month follow-up compared to the sham treatment.
Time Frame
Baseline to 3-month follow-up
Title
Change in Short Physical Performance Battery (SPPB) score
Description
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). The investigators will determine whether leg heat therapy improves the SPPB score at 3-month follow-up compared to the sham treatment.
Time Frame
Baseline to 3-month follow-up
Title
Change in handgrip strength
Description
The assessment of maximal handgrip strength will be will performed using a hand dynamometer. The investigators will determine whether leg heat therapy improves handgrip strength at 3-month follow-up compared to the sham treatment.
Time Frame
Baseline to 3-month follow-up
Title
Change in systolic blood pressure
Description
The systolic blood pressure will be measured in triplicate using a blood pressure monitor. The investigators will determine whether leg heat therapy improves systolic blood pressure at 3-month follow-up compared to the sham treatment.
Time Frame
Baseline to 3-month follow-up
Title
Change in diastolic blood pressure
Description
The diastolic blood pressure will be measured in triplicate using a blood pressure monitor. The investigators will determine whether leg heat therapy improves blood pressure at 3-month follow-up compared to the sham treatment.
Time Frame
Baseline to 3-month follow-up
Title
Change in triceps surae volume
Description
The volume of calf muscles will be determined using magnetic resonance (MR) images. The investigators will determine whether leg heat therapy improves calf muscle volume at 3-month follow-up compared to the sham treatment.
Time Frame
Baseline to 3-month follow-up
Title
Change in triceps surae intramuscular fat content
Description
The intramuscular fat content of calf muscles will be determined using magnetic resonance (MR) images. The investigators will determine whether leg heat therapy reduces intramuscular fat content at 3-month follow-up compared to the sham treatment.
Time Frame
Baseline to 3-month follow-up
Title
Change in the time constant for phosphocreatine recovery after dynamic exercise
Description
Magnetic resonance spectroscopy tuned to phosphorous (31PMRS) will be used to measure the time constant for PCr recovery (τ) after dynamic planar flexion exercise. The investigators will determine whether leg heat therapy reduces the time constant for PCr recovery at 3-month follow-up compared to the sham treatment.
Time Frame
Baseline to 3-month follow-up
Title
Change in maximal plantar flexor strength
Description
The maximal voluntary contraction (MVC) strength of the plantar flexor muscles will be assessed using an MR-compatible ergometer (Trispect, Ergospect GmbH, Innsbruck, Austria), Participants will be asked to perform three 4-5 s plantar-flexor MVCs separated by a one-minute rest period. The MVC torque will be considered the highest peak torque value measured over the three trials.
Time Frame
Baseline to 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women older than 60 years Resting ankle-brachial index (ABI) of 0.9 or less in at least one leg. Individuals with a resting ABI between 0.91 and 1.00 at baseline will be eligible if their ABI drops by 20% or greater following a heel-rise test. Exclusion Criteria: Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss) Prior foot or leg amputation Exercise tolerance limited by factors other than leg pain (e.g. angina, arthritis, severe lung disease, etc). Recent (<3 months) lower-extremity revascularization or orthopedic surgery Use of walking aid other than a cane Active 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 A Mini-Mental Status Examination score <23 Impaired thermal sensation in the leg As this study involves MR imaging, patients that have contraindications to MRI will be included in the study but will not be allowed to participate in the MRI experiment. Information about biomedical devices that may pose a risk to patients undergoing MRI is available on the Internet at www.MRIsafety.com. These exclusions include: cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, cochlear, otologic, or ear implant and history of claustrophobia or who are unable to lie flat or who do not fit inside the bore of the scanner.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janet Klein, RN
Phone
(317) 962-0287
Email
jswklein@iupui.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Roseguini, Ph.D.
Phone
(765) 496-2612
Email
brosegui@purdue.edu
Facility Information:
Facility Name
Indiana University Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Klein, RN
Phone
317-962-0287
Email
jswklein@iupui.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Leg Heat Therapy in Peripheral Artery Disease

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