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Heat Therapy to Reduce Pain and Improve Walking Tolerance

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control/Sham Treatment
Heat Therapy (HT)
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

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

Inclusion Criteria:

  • Men and women with stable symptomatic leg claudication for 6 months or longer.
  • Ankle brachial index < 0.9

Exclusion Criteria:

  • Heart Failure
  • COPD
  • Critical limb ischemia
  • Prior amputation
  • Exercise-limiting co-morbidity
  • Recent infrainguinal revascularization or planned during study period
  • Plans to change medical therapy during duration of the study
  • Active cancer
  • Chronic kidney disease
  • HIV positive, active HBV or HCV disease
  • Presence of any unsuitable comorbid clinical condition in the opinion of the PI
  • Peripheral neuropathy, numbness or paresthesia in the legs
  • Morbid obesity, BMI > 36 or unable to fit in water-circulating pants
  • Open wounds or ulcers on the extremity
  • Unable to walk on the treadmill

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sham, then heat therapy

Heat therapy, then sham

Arm Description

Participants were fitted with liquid-circulating trousers. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the heat therapy (HT) treatment. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC.

Participants were fitted with liquid-circulating trousers. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC. At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the sham treatment. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).

Outcomes

Primary Outcome Measures

Peak Walking Time
Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT).

Secondary Outcome Measures

Claudication Onset Time
Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT).
Peak Systolic Blood Pressure
Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer during exercise.
Peak Diastolic Blood Pressure
Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer prior and during exercise
Peak Calf Tissue Saturation Index
The tissue saturation index (TSI%) of the most symptomatic leg was assessed with a commercially available NIRS system (Portamon, Artinis Medical Systems, The Netherlands).
Post-exercise Plasma Endothelin-1 Concentration
Commercially available enzyme-linked immunosorbent assay kits were used to measure the plasma concentrations of ET-1 (DET100, Endothelin-1 Quantikine ELISA Kit, R&D Systems, Minneapolis, MN, United States)

Full Information

First Posted
October 27, 2017
Last Updated
August 7, 2022
Sponsor
Indiana University
Collaborators
Roseguini, Bruno, PhD, Michael Emery, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03435835
Brief Title
Heat Therapy to Reduce Pain and Improve Walking Tolerance
Official Title
Heat Therapy to Reduce Leg Pain and Improve Walking Tolerance in Patients With Symptomatic Peripheral Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 14, 2019 (Actual)
Study Completion Date
August 14, 2019 (Actual)

3. Sponsor/Collaborators

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

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 purpose of this study is to investigate whether exposure to heat therapy improves calf muscle oxygenation and enhances walking tolerance in patients with symptomatic Peripheral Arterial Disease (PAD).
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 study is to establish evidence to support the validity of HT in improving walking tolerance on PAD patents. Subjects will complete baseline assessments for eligibility, including medical history and ankle-brachial measurement. Eligible participants will be asked to report to the laboratory on 4 different occasions. The purpose of visits 1 and 2 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. is to familiarize the participants with the treadmill walking test and assess the test-retest reliability of maximal walking time determination. On visits 3 and 4 participants will receive either heat treatment or a control treatment for 80 min prior to undergoing a symptom-limited incremental test on the treadmill.

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
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Subjects will not be told outright which therapy there are receiving (thermoneutral or HT) and the Cardiologist supervising the exercise test will not be told which therapy was given.
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham, then heat therapy
Arm Type
Experimental
Arm Description
Participants were fitted with liquid-circulating trousers. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the heat therapy (HT) treatment. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC.
Arm Title
Heat therapy, then sham
Arm Type
Experimental
Arm Description
Participants were fitted with liquid-circulating trousers. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC. At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the sham treatment. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).
Intervention Type
Device
Intervention Name(s)
Control/Sham Treatment
Intervention Description
Water at 33ºC was circulated through water-circulating trousers.
Intervention Type
Device
Intervention Name(s)
Heat Therapy (HT)
Intervention Description
Water at 42-43ºC was circulated through the water-circulating trousers.
Primary Outcome Measure Information:
Title
Peak Walking Time
Description
Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT).
Time Frame
Immediately after exposure to a single session of heat therapy or sham treatment, up to ~20 min
Secondary Outcome Measure Information:
Title
Claudication Onset Time
Description
Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT).
Time Frame
The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min
Title
Peak Systolic Blood Pressure
Description
Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer during exercise.
Time Frame
The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min
Title
Peak Diastolic Blood Pressure
Description
Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer prior and during exercise
Time Frame
The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min
Title
Peak Calf Tissue Saturation Index
Description
The tissue saturation index (TSI%) of the most symptomatic leg was assessed with a commercially available NIRS system (Portamon, Artinis Medical Systems, The Netherlands).
Time Frame
The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min
Title
Post-exercise Plasma Endothelin-1 Concentration
Description
Commercially available enzyme-linked immunosorbent assay kits were used to measure the plasma concentrations of ET-1 (DET100, Endothelin-1 Quantikine ELISA Kit, R&D Systems, Minneapolis, MN, United States)
Time Frame
The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min. Ten minutes following completion of the incremental treadmill test, blood samples were obtained for the assessment of serum ET-1

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women with stable symptomatic leg claudication for 6 months or longer. Ankle brachial index < 0.9 Exclusion Criteria: Heart Failure COPD Critical limb ischemia Prior amputation Exercise-limiting co-morbidity Recent infrainguinal revascularization or planned during study period Plans to change medical therapy during duration of the study Active cancer Chronic kidney disease HIV positive, active HBV or HCV disease Presence of any unsuitable comorbid clinical condition in the opinion of the PI Peripheral neuropathy, numbness or paresthesia in the legs Morbid obesity, BMI > 36 or unable to fit in water-circulating pants Open wounds or ulcers on the extremity Unable to walk on the treadmill
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raghu L Motaganahalli, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Heat Therapy to Reduce Pain and Improve Walking Tolerance

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