Aging WellPhase 1/2NCT05706181
Heat Therapy, Functional Capacity, and Vascular Health in Older Adults
A Phase 1/2 study testing Home-based leg heat therapy in people with Aging Well and Walking, Difficulty, run by University of North Texas Health Science Center at 1 site in United States.
Trial summary
To test the hypothesis that home-based leg heat therapy improves functional capacity, vascular function, and exercise hyperemia in older adults. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging Well, Walking, Difficulty, Hyperemia
- What is being tested?
- Home-based leg heat therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 30 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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) <40 unless athletic/muscular build; calculation = body weight (kg)/height (m2)
- Females Only: Post-menopausal
Who cannot join
- 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
Show all 26Show fewer
- 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, methacholine chloride, 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Texas Health Science Center
Fort Worth, Texas, 76107
About this study
Official title: Home-based Heat Therapy to Improve Functional Capacity and Vascular Health in Older Adults
To test the hypothesis that home-based leg heat therapy improves functional capacity, vascular function, and exercise hyperemia in older adults.
Read the 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.
- Conditions
- Aging Well, Walking, Difficulty, Hyperemia
- Being tested
- Home-based leg heat therapy, Home-based sham therapy
- Keywords
- Healthy aging, Functional capacity, Exercise hyperemia, Vascular function, heat therapy
- Medical subject headings
- Mobility Limitation, Hyperemia, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based leg heat therapyOther
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 sham therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Home-based leg heat therapy; Other: Home-based sham therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
The distance, in meters, covered while walking for 6 minutes will be used to assess functional capacity.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 8 weeks of heat therapy or sham
Secondary outcomes (2)
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.
Measured: Before sham or heat therapy
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.
Measured: After 8 weeks of heat therapy or sham
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start3 Nov 2022
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging WellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706181
- Sponsor's protocol ID
- UNorthTexas
- Status last verified
- Jun 2026
- First submitted
- 21 Dec 2022
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Heat Therapy to Improve Functional Capacity and Vascular Health in Older Adults
- ClinicalTrials.gov ID
- NCT05706181
- Acronym / sponsor ID
- UNorthTexas
- Conditions
- Aging Well, Walking, Difficulty, Hyperemia
- Keywords
- Healthy aging, Functional capacity, Exercise hyperemia, Vascular function, heat therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based heat therapy and functional capacity in older adults | Experimental | Other: Home-based leg heat therapy, Other: Home-based sham therapyThe 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. |
| Home-based heat therapy and vascular function and exercise hyperemia in older adults | Experimental | Other: Home-based leg heat therapy, Other: Home-based sham therapyThe 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based leg heat therapyParticipants 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. | Other | 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 therapyParticipants 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. | Other | Home-based heat therapy and functional capacity in older adults, Home-based heat therapy and vascular function and exercise hyperemia in older adults |
Primary outcome
6 minute walk test
Time frame: Before sham or heat therapy
The distance, in meters, covered while walking for 6 minutes will be used to assess functional capacity.
6 minute walk test
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.
Macrovascular function
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.
Macrovascular function
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.
Microvascular function
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.
Microvascular function
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.
Blood flow response to exercise
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.
Blood flow response to 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.
2 secondary outcomes
Physical performance Battery
Time frame: Before sham or heat therapy
Physical performance Battery
Time frame: After 8 weeks of heat therapy or sham
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Laboratory websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Home-based leg heat therapy in people with Aging Well and Walking, Difficulty, run by University of North Texas Health Science Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test (time frame: Before sham or heat therapy). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.