Heat Therapy, Functional Capacity, and Vascular Health in Older Adults

NCT05706181 | Recruiting Phase 1

• 1 other identifier: UNorthTexas
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

To test the hypothesis that home-based leg heat therapy improves functional capacity, vascular function, and exercise hyperemia in older adults.

Conditions

Aging Well; Walking, Difficulty; Hyperemia

Keywords

Healthy aging; Functional capacity; Exercise hyperemia; Vascular function; heat therapy

Outcome Measures

Primary Outcomes (8)

• 6 minute walk test

  The distance, in meters, covered while walking for 6 minutes will be used to assess functional capacity.

  Before sham or heat therapy

• 6 minute walk test

  The distance, in meters, covered while walking for 6 minutes will be used to assess functional capacity.

  After 8 weeks of heat therapy or sham

• Macrovascular function

  High-resolution duplex ultrasound will be used to assess vasodilation following a 5 minutes of leg ischemia. Vasodilation will calculated as the percent change in diameter of the superficial femoral that occurs following ischemia.

  Before sham or heat therapy

• Macrovascular function

  High-resolution duplex ultrasound will be used to assess vasodilation following a 5 minutes of leg ischemia. Vasodilation will calculated as the percent change in diameter of the superficial femoral that occurs following ischemia.

  After 8 weeks of heat therapy or sham

• Microvascular function

  The microdialysis technique will be used to delivery small amounts of acetylcholine or methacholine and sodium nitroprusside to the skeletal muscle of the thigh. Endothelial-dependent and endothelial-independent microvascular function can then be examined by assessing the increase in skeletal muscles blood flow during the infusion of acetylcholine/methacholine and sodium nitroprusside, respectively.

  Before sham or heat therapy

• Microvascular function

  The microdialysis technique will be used to delivery small amounts of acetylcholine or methacholine and sodium nitroprusside to the skeletal muscle of the thigh. Endothelial-dependent and endothelial-independent microvascular function can then be examined by assessing the increase in skeletal muscles blood flow during the infusion of acetylcholine/methacholine and sodium nitroprusside, respectively.

  After 8 weeks of heat therapy or sham

• Blood flow response to exercise

  High-resolution duplex ultrasound will be used to assess the change in blood flow during graded plantar flexion exercise.

  Before sham or heat therapy

• Blood flow response to exercise

  High-resolution duplex ultrasound will be used to assess the change in blood flow during graded plantar flexion exercise.

  After 8 weeks of heat therapy or sham

Secondary Outcomes (2)

• Physical performance Battery

  Before sham or heat therapy

• Physical performance Battery

  After 8 weeks of heat therapy or sham

Study Arms (2)

Home-based heat therapy and functional capacity in older adults

EXPERIMENTAL

The investigators will determine the extent to which home-based leg heat therapy improves functional capacity in older adults. Functional capacity will be assessed before and after heat therapy or sham intervention via the 6-min walk test and the Short Physical Performance Battery.

Other: Home-based leg heat therapy; Other: Home-based sham therapy

Home-based heat therapy and vascular function and exercise hyperemia in older adults

EXPERIMENTAL

The investigators will determine if home-based leg heat therapy improves vascular function and exercise hyperemia in the older adults of Aim 1. Using state-of-the-art techniques of skeletal muscle microdialysis and high-resolution duplex ultrasound, the investigators will pharmacodissect mechanisms of vascular function and exercise hyperemia before and after each intervention. The outcomes of Aim 2, while providing insight into the mechanisms whereby heat therapy improves functional capacity, should be considered independent of the outcomes of Aim 1 given that vascular health is a key independent, yet modifiable risk factor for cardiovascular morbidity and mortality.

Other: Home-based leg heat therapy; Other: Home-based sham therapy

Interventions

Home-based leg heat therapy OTHER

Participants will be required to perform 8 weeks of leg heat therapy using water-perfused pants 4 times per week, with each session lasting 60 min. Skin temperature will be heated to about 40 °C. The pants heating system (consisting of pants and a water circulator/heater) can finely and uniformly control these designated skin temperatures. Participants will be randomly assigned to a group and provided with the pant heating system as well as a log book in which they are required to track the dates of each session. Participants will also measure their blood pressure and heart rate prior to, during, and immediately after each heating session using a portable oscillometric device provided by our laboratory.

Home-based heat therapy and functional capacity in older adults; Home-based heat therapy and vascular function and exercise hyperemia in older adults

Home-based sham therapy OTHER

Participants will be required to perform 8 weeks of leg heat therapy using water-perfused pants 4 times per week, with each session lasting 60 min. Skin temperature will be heated to about 40 °C. The pants heating system (consisting of pants and a water circulator/heater) can finely and uniformly control these designated skin temperatures. Participants will be randomly assigned to a group and provided with the pant heating system as well as a log book in which they are required to track the dates of each session. Participants will also measure their blood pressure and heart rate prior to, during, and immediately after each heating session using a portable oscillometric device provided by our laboratory.

Home-based heat therapy and functional capacity in older adults; Home-based heat therapy and vascular function and exercise hyperemia in older adults

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age
• No tobacco/nicotine use within preceding 6 months (e.g., cigarettes, chewing tobacco, nicotine gum or patches, and vapor smoking)
• Systolic blood pressure \<140 mmHg; diastolic blood pressure \<90 mmHg
• Normal 12-lead ECG (reviewed by a physician)
• Normal clinical results from a medical exam reviewed by a board-certified physician (e.g., General Health Questionnaire - see attached document)
• Body mass index (BMI) \<40 unless athletic/muscular build; calculation = body weight (kg)/height (m2)
• Females Only: Post-menopausal

You may not qualify if:

• Not meeting the age criteria
• Body mass index (BMI) \>40 unless athletic/muscular build; calculation = body weight (kg)/height (m2)
• Use of tobacco or nicotine products within the last 6 months (tobacco cigarettes, chewing tobacco, nicotine patches or gum)
• Not abstaining from the following 24 hours prior to the experimental session: exercise, alcoholic substances, prescription or non-prescription medications (unless cleared by the medical screener), dietary supplements, herbal medications, caffeinated substances (including chocolate, coffee, tea (iced or hot), caffeinated energy drinks, and sodas)
• S who weigh less than 80 lbs
• Use of prescription drugs, non-prescription drugs or herbal medicines known to alter vascular function unless cleared prior to the study
• Use of anti-hypertensive medications
• Use of beta blockers
• Daily use of bronchodilators
• Current use of anti-coagulant therapy
• Current use of hormone replacement therapy (e.g., estrogen, testosterone)
• Current diagnosis of cancer
• Signs of overt cardio-metabolic abnormalities (e.g., uncontrolled diabetes - HbA1c \>7.5, a resting systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg; abnormal 12-lead ECG)
• History of cerebrovascular abnormalities (e.g., prior stroke, transient ischemic attacks, epilepsy, increased intracranial pressure)
• Known history of atherosclerosis (i.e., plaque formation)

Sponsors & Collaborators

• University of North Texas Health Science Center: lead
• American Heart Association: collaborator

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

RECRUITING

Related Links

• Laboratory website

MeSH Terms

Conditions

Mobility Limitation; Hyperemia; Hyperthermia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries

Central Study Contacts

Steven A Romero, PhD

CONTACT

8177355159; steven.romero@unthsc.edu

Amy Moore, RN

CONTACT

8177352088

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: With the exception of a research nurse, all research personnel are blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 31, 2023
• Study Start: November 3, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)