Heat Therapy to Reduce Pain and Improve Walking Tolerance

• Sponsor: Indiana University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03435835
• Collaborator: Bruno Roseguini, PhD (Other), Michael Emery, MD (Other)
• Enrollment: 16
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 46
• Patients Per Site Per Month: 0.3

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Device: Control/Sham Treatment; Device: Heat Therapy (HT)	N/A

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.

Study Design

• Study Type: Interventional
• Actual 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: Mar 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Maximal and pain-free treadmill walking time [Immediately after exposure to heat therapy/control treatment]

2. Calf muscle oxygenation will be measured using near infrared spectroscopy [Before and during the exercise test]

3. Serum endothelin-1 concentrations [Before and 10 minutes after the exercise test]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University
• Bruno Roseguini, PhD
• Michael Emery, MD

Investigators

• Principal Investigator: Raghu L Motaganahalli, MD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raghu Motaganahalli, Associate Professor, Indiana University
• ClinicalTrials.gov Identifier: NCT03435835
• Other Study ID Numbers: 1708785351
• First Posted: Feb 19, 2018
• Last Update Posted: Feb 23, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases

Study Results

No Results Posted as of Feb 23, 2021