Heat Therapy to Reduce Pain and Improve Walking Tolerance

Indiana University

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Control/Sham Treatment; Device: Heat Therapy (HT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03435835

1708785351

Details and patient eligibility

About

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).

Full 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.

Enrollment: 19 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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19 participants in 2 patient groups

Sham, then heat therapy

Experimental group

Description:

Participants were fitted with liquid-circulating trousers. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the heat therapy (HT) treatment. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC.

Treatment:

Device: Heat Therapy (HT)

Device: Control/Sham Treatment

Heat therapy, then sham

Experimental group

Description:

Participants were fitted with liquid-circulating trousers. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC. At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the sham treatment. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).

Treatment:

Device: Heat Therapy (HT)

Device: Control/Sham Treatment