Clinical trial NCT03435835: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Roseguini, Bruno, PhD
name: Michael Emery, MD
First posted: 2018-02-19
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Peak Walking Time
timeFrame: Immediately after exposure to a single session of heat therapy or sham treatment, up to ~20 min
Secondary outcomes:
measure: Claudication Onset Time
timeFrame: The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min
measure: Peak Systolic Blood Pressure
timeFrame: The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min
measure: Peak Diastolic Blood Pressure
timeFrame: The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min
measure: Peak Calf Tissue Saturation Index
timeFrame: The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min
measure: Post-exercise Plasma Endothelin-1 Concentration
timeFrame: 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
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Raghu L Motaganahalli, MD
role: PRINCIPAL_INVESTIGATOR
References: