University of North Texas Health Science Center
Fort Worth, Texas, 76107, United States
NCT Number: NCT05706181
To test the hypothesis that home-based leg heat therapy improves functional capacity, vascular function, and exercise hyperemia in older adults.
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Notify Me55 year–80 year
All sexes
Interventional
Phase 1 / Phase 2
Fort Worth, Texas, 76107, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Before sham or heat therapy
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
The distance, in meters, covered while walking for 6 minutes will be used to assess functional capacity.
Time frame: Before sham or heat therapy
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
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
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.
Time frame: After 8 weeks of heat therapy or sham
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.
Time frame: Before sham or heat therapy
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
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
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
Likert scale-based scores will be tabulated from a side-by-side stand test, semi-tandem stand test, and a tandem stand test.
University of North Texas Health Science Center
Other
Home-based Heat Therapy to Improve Functional Capacity and Vascular Health in Older Adults
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