Heat Therapy to Reduce Pain and Improve Walking Tolerance

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03435835
• Other study ID #: 1708785351
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: August 14, 2019

Study information

• Verified date: August 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 14, 2019
• Est. primary completion date: August 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Control/Sham Treatment
Water at 33ºC was circulated through water-circulating trousers.
• Heat Therapy (HT)
Water at 42-43ºC was circulated through the water-circulating trousers.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Bruno Roseguini, PhD, Michael Emery, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Walking Time	Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT).	Immediately after exposure to a single session of heat therapy or sham treatment, up to ~20 min
Secondary	Claudication Onset Time	Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT).	The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min
Secondary	Peak Systolic Blood Pressure	Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer during exercise.	The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min
Secondary	Peak Diastolic Blood Pressure	Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer prior and during exercise	The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min
Secondary	Peak Calf Tissue Saturation Index	The tissue saturation index (TSI%) of the most symptomatic leg was assessed with a commercially available NIRS system (Portamon, Artinis Medical Systems, The Netherlands).	The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min
Secondary	Post-exercise Plasma Endothelin-1 Concentration	Commercially available enzyme-linked immunosorbent assay kits were used to measure the plasma concentrations of ET-1 (DET100, Endothelin-1 Quantikine ELISA Kit, R&D Systems, Minneapolis, MN, United States)	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