Heat Therapy to Reduce Pain and Improve Walking Tolerance

NCT03435835 | Completed Results DMC FDA Device

• 1 other identifier: 1708785351
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Claudication Onset Time

  The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min

• Peak Systolic Blood Pressure

  The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min

• Peak Diastolic Blood Pressure

  The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min

• Peak Calf Tissue Saturation Index

  The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min

• Post-exercise Plasma Endothelin-1 Concentration

  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

Study Arms (2)

Sham, then heat therapy

EXPERIMENTAL

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.

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

Heat therapy, then sham

EXPERIMENTAL

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).

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

Interventions

Control/Sham Treatment DEVICE

Water at 33ºC was circulated through water-circulating trousers.

Heat therapy, then sham; Sham, then heat therapy

Heat Therapy (HT) DEVICE

Water at 42-43ºC was circulated through the water-circulating trousers.

Heat therapy, then sham; Sham, then heat therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with stable symptomatic leg claudication for 6 months or longer.
• Ankle brachial index \< 0.9

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Roseguini, Bruno, PhD: collaborator
• Michael Emery, MD: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Results Point of Contact

• Title: Dr. Bruno Roseguini
• Organization: Purdue University/Indiana University

brosegui@purdue.edu

7654962612

Study Officials

• Raghu L Motaganahalli, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: February 19, 2018
• Study Start: August 1, 2018
• Primary Completion: August 14, 2019
• Study Completion: August 14, 2019
• Last Updated: August 30, 2022
• Results First Posted: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)