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

Primary Purpose

Aging Well, Walking, Difficulty, Hyperemia

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Home-based leg heat therapy
Home-based sham therapy
Sponsored by
University of North Texas Health Science Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Aging Well focused on measuring Healthy aging, Functional capacity, Exercise hyperemia, Vascular function, heat therapy

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 55 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) <35 unless athletic/muscular build; calculation = body weight (kg)/height (m2) Females Only: Post-menopausal Exclusion Criteria: Not meeting the age criteria Body mass index (BMI) >35 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) Autonomic dysfunction (e.g., Shy-Drager Syndrome, Bradbury-Eggleston syndrome, idiopathic orthostatic hypotension) Respiratory illnesses (e.g., chronic asthma (including exercise-induced asthma), Chronic Obstructive Pulmonary Disease, Reactive Airway Disease). Note: subjects with exercised-induced asthma or who have had COVID-19 will be allowed to participate History of anaphylaxis Severe phobia of needles History of alcohol or drug abuse which inhibits the participants ability to complete this study Latex allergy Known allergies or sensitivities to drugs used in the study (e.g., Lidocaine HCL, acetylcholine HCL, sodium nitroprusside, nitroglycerin, or related drugs) Implanted electronic medical devices (e.g. cardiac pacemaker) Tissue or skin abnormalities of the legs (e.g., infection, injury, open wound, ischemic tissue, phlebitis, active bleeding, neuropathy) Tissue or skin abnormalities of the arm (e.g., unhealed or open wound or circulatory deficits) Current Fever (oral temp >99.5 °F/ 37.5 °C) aa) Current use of PDE3 inhibitors (e.g., Viagra) or soluble guanylate cyclase (sGC) stimulators (e.g., riociguat), or unwillingness to withhold medication for 2 weeks prior to laboratory testing bb) Diagnosis of neurological disease or cognitive dysfunction cc) Cardiac surgery or cardiac events (e.g., coronary artery bypass graft surgery, myocardial infarction, heart failure) dd) Abnormal clotting, clots in deep veins in the legs or pelvis, or blood clots to the lungs ee) Individuals who have had mastectomies ff) History of methemoglobinemia

Sites / Locations

  • University of North Texas Health Science CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Home-based heat therapy and functional capacity in older adults

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

6 minute walk test
The distance, in meters, covered while walking for 6 minutes will be used to assess functional capacity.
6 minute walk test
The distance, in meters, covered while walking for 6 minutes will be used to assess functional capacity.
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.
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.
Microvascular function
The microdialysis technique will be used to delivery small amounts of acetylcholine 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 and sodium nitroprusside, respectively.
Microvascular function
The microdialysis technique will be used to delivery small amounts of acetylcholine 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 and sodium nitroprusside, respectively.
Blood flow response to exercise
High-resolution duplex ultrasound will be used to assess the change in blood flow during graded plantar flexion exercise.
Blood flow response to exercise
High-resolution duplex ultrasound will be used to assess the change in blood flow during graded plantar flexion exercise.

Secondary Outcome Measures

Physical performance Battery
Likert scale-based scores will be tabulated from a side-by-side stand test, semi-tandem stand test, and a tandem stand test.
Physical performance Battery
Likert scale-based scores will be tabulated from a side-by-side stand test, semi-tandem stand test, and a tandem stand test.

Full Information

First Posted
December 21, 2022
Last Updated
January 20, 2023
Sponsor
University of North Texas Health Science Center
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT05706181
Brief Title
Heat Therapy, Functional Capacity, and Vascular Health in Older Adults
Official Title
Home-based Heat Therapy to Improve Functional Capacity and Vascular Health in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
July 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Texas Health Science Center
Collaborators
American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To test the hypothesis that home-based leg heat therapy improves functional capacity, vascular function, and exercise hyperemia in older adults.
Detailed Description
Chronic whole-body heating (i.e., heat therapy) has gained attention as a novel strategy to improve clinical and physiological outcomes in a number of populations. However, whole-body heat therapy is quite uncomfortable and may require trained personnel to ensure participant safety, especially for those more at risk for heat-related illness. Moreover, the applicability and acceptability of whole-body heat therapy are questionable as equipment cost is substantial and adherence will be low if individuals are required to travel if they cannot afford in-home therapy. Home-based leg heat therapy offers an opportunity to leverage the demonstrated benefits of whole-body heat therapy while managing safety and convenience. The hypothesis will be addressed in the following Specific Aims: Aim 1: 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. Aim 2: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging Well, Walking, Difficulty, Hyperemia
Keywords
Healthy aging, Functional capacity, Exercise hyperemia, Vascular function, heat therapy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
With the exception of a research nurse, all research personnel are blinded.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based heat therapy and functional capacity in older adults
Arm Type
Experimental
Arm Description
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.
Arm Title
Home-based heat therapy and vascular function and exercise hyperemia in older adults
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Home-based leg heat therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Home-based sham therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
6 minute walk test
Description
The distance, in meters, covered while walking for 6 minutes will be used to assess functional capacity.
Time Frame
Before sham or heat therapy
Title
6 minute walk test
Description
The distance, in meters, covered while walking for 6 minutes will be used to assess functional capacity.
Time Frame
After 8 weeks of heat therapy or sham
Title
Macrovascular function
Description
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.
Time Frame
Before sham or heat therapy
Title
Macrovascular function
Description
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.
Time Frame
After 8 weeks of heat therapy or sham
Title
Microvascular function
Description
The microdialysis technique will be used to delivery small amounts of acetylcholine 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 and sodium nitroprusside, respectively.
Time Frame
Before sham or heat therapy
Title
Microvascular function
Description
The microdialysis technique will be used to delivery small amounts of acetylcholine 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 and sodium nitroprusside, respectively.
Time Frame
After 8 weeks of heat therapy or sham
Title
Blood flow response to exercise
Description
High-resolution duplex ultrasound will be used to assess the change in blood flow during graded plantar flexion exercise.
Time Frame
Before sham or heat therapy
Title
Blood flow response to exercise
Description
High-resolution duplex ultrasound will be used to assess the change in blood flow during graded plantar flexion exercise.
Time Frame
After 8 weeks of heat therapy or sham
Secondary Outcome Measure Information:
Title
Physical performance Battery
Description
Likert scale-based scores will be tabulated from a side-by-side stand test, semi-tandem stand test, and a tandem stand test.
Time Frame
Before sham or heat therapy
Title
Physical performance Battery
Description
Likert scale-based scores will be tabulated from a side-by-side stand test, semi-tandem stand test, and a tandem stand test.
Time Frame
After 8 weeks of heat therapy or sham

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 55 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) <35 unless athletic/muscular build; calculation = body weight (kg)/height (m2) Females Only: Post-menopausal Exclusion Criteria: Not meeting the age criteria Body mass index (BMI) >35 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) Autonomic dysfunction (e.g., Shy-Drager Syndrome, Bradbury-Eggleston syndrome, idiopathic orthostatic hypotension) Respiratory illnesses (e.g., chronic asthma (including exercise-induced asthma), Chronic Obstructive Pulmonary Disease, Reactive Airway Disease). Note: subjects with exercised-induced asthma or who have had COVID-19 will be allowed to participate History of anaphylaxis Severe phobia of needles History of alcohol or drug abuse which inhibits the participants ability to complete this study Latex allergy Known allergies or sensitivities to drugs used in the study (e.g., Lidocaine HCL, acetylcholine HCL, sodium nitroprusside, nitroglycerin, or related drugs) Implanted electronic medical devices (e.g. cardiac pacemaker) Tissue or skin abnormalities of the legs (e.g., infection, injury, open wound, ischemic tissue, phlebitis, active bleeding, neuropathy) Tissue or skin abnormalities of the arm (e.g., unhealed or open wound or circulatory deficits) Current Fever (oral temp >99.5 °F/ 37.5 °C) aa) Current use of PDE3 inhibitors (e.g., Viagra) or soluble guanylate cyclase (sGC) stimulators (e.g., riociguat), or unwillingness to withhold medication for 2 weeks prior to laboratory testing bb) Diagnosis of neurological disease or cognitive dysfunction cc) Cardiac surgery or cardiac events (e.g., coronary artery bypass graft surgery, myocardial infarction, heart failure) dd) Abnormal clotting, clots in deep veins in the legs or pelvis, or blood clots to the lungs ee) Individuals who have had mastectomies ff) History of methemoglobinemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven A Romero, PhD
Phone
8177355159
Email
steven.romero@unthsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Moore, RN
Phone
8177352088
Facility Information:
Facility Name
University of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Moore, RN
Phone
817-735-2088
Email
amy.moore@unthsc.edu
First Name & Middle Initial & Last Name & Degree
Steven Romero, PhD
First Name & Middle Initial & Last Name & Degree
Heidi Cope, BS

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://unthsc.edu/romerolab
Description
Laboratory website

Learn more about this trial

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

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