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Completed

NCT Number: NCT03435835

Heat Therapy to Reduce Pain and Improve Walking Tolerance

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).

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control/Sham Treatment

Device

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

Heat Therapy (HT)

Device

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

Primary outcomes

  1. Peak Walking Time

    Time frame: Immediately after exposure to a single session of heat therapy or sham treatment, up to ~20 min

    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).

Secondary outcomes

  1. Claudication Onset Time

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

    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).

  2. Peak Systolic Blood Pressure

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

    Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer during exercise.

  3. Peak Diastolic Blood Pressure

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

    Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer prior and during exercise

  4. Peak Calf Tissue Saturation Index

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

    The tissue saturation index (TSI%) of the most symptomatic leg was assessed with a commercially available NIRS system (Portamon, Artinis Medical Systems, The Netherlands).

  5. Post-exercise Plasma Endothelin-1 Concentration

    Time frame: 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

    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)

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Michael Emery, MD
  • Roseguini, Bruno, PhD

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2018
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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