Heat Therapy to Reduce Pain and Improve Walking Tolerance



Status:Recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:4/17/2018
Start Date:March 1, 2018
End Date:December 31, 2018
Contact:Bruno T Roseguini, PhD
Email:brosegui@purdue.edu
Phone:765-496-2612

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Heat Therapy to Reduce Leg Pain and Improve Walking Tolerance in Patients With Symptomatic Peripheral Artery Disease

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).

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.

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
We found this trial at
1
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Phone: 765-490-6284
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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