Heat Therapy to Reduce Pain and Improve Walking Tolerance
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|ClinicalTrials.gov Identifier: NCT03435835|
Recruitment Status : Enrolling by invitation
First Posted : February 19, 2018
Last Update Posted : May 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: Control/Sham Treatment Device: Heat Therapy (HT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|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.|
|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|
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.
- Maximal and pain-free treadmill walking time [ Time Frame: Immediately after exposure to heat therapy/control treatment ]
- Calf muscle oxygenation will be measured using near infrared spectroscopy [ Time Frame: Before and during the exercise test ]
- Serum endothelin-1 concentrations [ Time Frame: Before and 10 minutes after the exercise test ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435835
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Raghu L Motaganahalli, MD||Indiana University|