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Heat Therapy to Reduce Pain and Improve Walking Tolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435835
Recruitment Status : Enrolling by invitation
First Posted : February 19, 2018
Last Update Posted : May 3, 2019
Sponsor:
Collaborators:
Bruno Roseguini, PhD
Michael Emery, MD
Information provided by (Responsible Party):
Raghu Motaganahalli, Indiana University

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).

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Control/Sham Treatment Device: Heat Therapy (HT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes 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.
Primary Purpose: Treatment
Official Title: Heat Therapy to Reduce Leg Pain and Improve Walking Tolerance in Patients With Symptomatic Peripheral Artery Disease
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Thermoneutral
Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33ºC will be circulated through the pants for 80 minutes.
Device: Control/Sham Treatment
Thermoneutral water (33ºC) will be circulated through water-circulating trousers to maintain skin temperature at baseline levels.

Active Comparator: Heat Therapy
Participants will be dressed in water circulating trousers that are connected to. Warm water (42-43ºC) will be circulated through the pants for 80 minutes.
Device: Heat Therapy (HT)
Water at 42-43ºC will be circulated through the water-circulating trousers.




Primary Outcome Measures :
  1. Maximal and pain-free treadmill walking time [ Time Frame: Immediately after exposure to heat therapy/control treatment ]
  2. Calf muscle oxygenation will be measured using near infrared spectroscopy [ Time Frame: Before and during the exercise test ]
  3. Serum endothelin-1 concentrations [ Time Frame: Before and 10 minutes after the exercise test ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435835


Locations
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United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Bruno Roseguini, PhD
Michael Emery, MD
Investigators
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Principal Investigator: Raghu L Motaganahalli, MD Indiana University
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Responsible Party: Raghu Motaganahalli, Associate Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03435835    
Other Study ID Numbers: 1708785351
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases