AgingNCT05622747
Acute Passive Heating in Healthy Older Adults
A study testing Passive heating in people with Aging, run by University of Portsmouth at 1 site in United Kingdom.
Trial summary
Aging is associated with a decline in cardiovascular health, cognitive function and losses in muscle strength, with half or more of those over age 65 suffering from two or more comorbidities (e.g., heart disease, type 2 diabetes). Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Passive heating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 May 2023to 24 Jul 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female age ≥ 55
- Free from cardiometabolic disease
- Body mass index of 18-35 kg/m2
- Receipt of a normal 12-lead ECG approved by the School Independent Medical Officer
- Capacity to understand and provide their written, informed consent to participate in the study protocol
Who cannot join
- Unable to understand or cooperate with the study protocol due to learning difficulties or otherwise
- Any current, or past medical (last five years), history of any cardiovascular, respiratory, cancer, renal, hepatic, gastrointestinal, haematological, lymphatic, neurological, psychiatric, or any other disease or diseases.
- Any regular medication for the last five years (not including acute courses of treatment of less than one month for discrete, resolved conditions).
- Medications that may influence physiological responses to the passive heating intervention Uncontrolled hypertension (≥ 150 mmHg systolic and/or ≥ 90 mmHg diastolic)
- Body mass index of > 35 kg/m2
- Recent long-term exposure to a hot climate (within the previous three months)
- Current smoker (or have stopped smoking within the previous three months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Time Course of Cardiovascular Function, Cognitive Function and Heat Shock Proteins in Response to Acute Passive Heating in Older Adults
Aging is associated with a decline in cardiovascular health, cognitive function and losses in muscle strength, with half or more of those over age 65 suffering from two or more comorbidities (e.g., heart disease, type 2 diabetes). The worldwide population of older adults is growing rapidly, with one in six people expected to be over age 65 by 2050. This will place further financial burden from chronic diseases on already stressed healthcare systems. While studies show that frequent exercise is an effective way for older adults to maintain or improve cardiovascular and metabolic health, older individuals are less physically active and do not adhere well to exercise programs, often due to physical or medical limitations. Therefore, alternative methods for older adults to get the same health benefits as exercise require further exploration. Recent work has shown a single session of passive heat therapy could be an alternative way to improve cardiovascular health and cognitive function in various populations, however, the length of time that these benefits last is yet to be explored.
Read the detailed description
Aging is associated with declines in cardiovascular health and cognitive function as well as chronic inflammation and the development of neurodegenerative conditions such as Alzheimer's and Parkinson's disease. Additionally, ageing results in a loss of muscle size and strength, commonly referred to as sarcopenia, leading to increased risk of falls or adverse exercise-related events. It is well understood that frequent exercise improves cardiovascular and metabolic health whilst lowering the risk of disease and all-cause mortality, acting as a treatment for many different health conditions. Despite the evidence of its efficacy, many individuals struggle with adherence to exercise programmes, particularly older adults and clinical populations, with many individuals within these populations unable to perform exercise due to physical limitations or medical contraindications. With one in six people expected to be over the age of 65 years by 2050 and corresponding increases in non-communicable diseases (e.g., cancer, diabetes, cardiovascular disease) anticipated from this aging population, the development of adjunct treatments or alternatives to exercise to improve general health in older populations is needed.
Recent work has shown one such potential solution could be the use of passive heat therapy (PHT) (e.g., hot water immersion, sauna), which can achieve health benefits comparable to exercise. Acute PHT induces vascular improvements including increased blood flow, reduced blood pressure. and macro- and microvascular dilator function in various populations. Acute PHT has also been shown to increase reaction time, while mixed results have been seen in its effect on executive function in both young and older populations. The mechanisms for these improvements, however, are currently unclear, and may be related to increases in nitric oxide activity or reductions in biomarkers of inflammation.
One potential mechanism for the physiological benefits obtained from PHT is the increase of cytoprotective heat shock proteins (HSP) (specifically HSP27, HSP60, HSP70 and HSP90) intracellularly (i) and extracellularly (e) in response to increases in deep body temperature. Increases in the expression of these HSPs have been shown to play a role in reducing inflammation and protecting the vasculature via increases in endothelial nitric oxide synthase activity. Increased HSP concentrations may also prevent the accumulation of harmful biomarkers in the brain that play a role in cognitive decline and development of neurodegenerative diseases. There is also evidence that increased preoperative levels of both iHSP70 and eHSP70 are correlated with improved postoperative outcomes following cardiac surgery. Aging, however, is associated with a reduction in HSP transcription activity in various tissues, resulting in an impaired heat shock response and development of a pro-inflammatory state.
Previous work using acute hot water immersion has shown mixed results, with various studies showing increases in eHSP70, iHSP70 and iHSP90, while others have reported no change in expression. Heating stimuli applied in these studies has varied in magnitude, duration and whole body or not, and measurements of HSPs have taken place at various time points before, during and after PHT. Therefore, it is possible that upregulation of HSPs may have been missed, as no time course relationship exists between a single bout of PHT and upregulation of HSPs. Additionally, the duration for acute vascular and cognitive benefits from PHT and when function is returned to baseline is yet to be determined. A time course relationship study to determine the peak HSP response to acute passive heat therapy in older adults would provide insight into the relationship between acute changes in vascular or cognitive function and concurrent upregulation of both intracellular and extracellular HSPs, as well as its potential implications for improved surgical outcomes.
- Conditions
- Aging
- Being tested
- Passive heating
- Keywords
- Passive heating, Endothelial function, Heat shock proteins, Cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive heatingOther
1 h hot water immersion (to the clavicle, @40°C, rectal temperature ~38.5°C and <39°C)
| Study group | Role | What they receive |
|---|---|---|
| Passive heating intervention | Experimental | 1 h hot water immersion (to the clavicle, @40°C, rectal temperature ~38.5°C and <39°C) Receives: Other: Passive heating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow-mediated dilation
Percentage change in brachial artery diameter and return to baseline as assessed by ultrasound.
Measured: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Secondary outcomes (22)
Brachial and carotid artery blood flow velocity
Change from baseline in blood flow velocity of the brachial artery and right common carotid artery as assessed via ultrasound. cm/s is the unit.
Measured: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Carotid vessel diameter
Change in vessel diameter of the right common carotid artery and return to baseline as assessed via ultrasound. mm is the unit.
Measured: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Carotid intima-media thickness
Change in intima-media thickness of the right common carotid artery and return to baseline as assessed via ultrasound. mm is the unit.
Measured: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Carotid compliance
Change in compliance of the right common carotid artery and return to baseline as assessed via ultrasound. µm^2 per kilopascal is the unit.
Measured: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Carotid distensibility
Change in distensibility of the right common carotid artery and return to baseline as assessed via ultrasound. 10^-3/kPa is the unit.
Measured: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Carotid stiffness
Change in stiffness of the right common carotid artery and return to baseline as assessed via ultrasound. Meters per second is the unit.
Measured: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Microvascular function
Change in microvascular function and return to baseline as assessed via iontophoresis on the forearm with acetylcholine (Ach) and Insulin, Area under the curve is the unit.
Measured: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Stroke volume
Change in stroke volume and return to baseline measured noninvasively via thoracic impedance. mL/m^2 is the unit
Measured: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Total peripheral resistance
Change in total peripheral resistance and return to baseline measured noninvasively via thoracic impedance
Measured: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Cardiac output
Change in cardiac output and return to baseline measured noninvasively via thoracic impedance. L/min is the unit.
Measured: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Intracellular HSP27 concentration
Change in iHSP27 concentration and return to baseline. Measured via immunoblotting in peripheral blood mononuclear cells (PBMCs).
Measured: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Intracellular HSP60 concentration
Change in iHSP60 concentration and return to baseline. Measured via immunoblotting in peripheral blood mononuclear cells (PBMCs).
Measured: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Intracellular HSP70 concentration
Change in iHSP70 concentration and return to baseline. Measured via immunoblotting in peripheral blood mononuclear cells (PBMCs).
Measured: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Intracellular HSP90 concentration
Change in iHSP90 concentration and return to baseline. Measured via immunoblotting in peripheral blood mononuclear cells (PBMCs).
Measured: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Plasma eHSP27 concentration
Change in plasma eHSP27 concentration and return to baseline. Measured via ELISA.
Measured: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Plasma eHSP60 concentration
Change in plasma eHSP60 concentration and return to baseline. Measured via ELISA.
Measured: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Plasma eHSP70 concentration
Change in plasma eHSP70 concentration and return to baseline. Measured via ELISA.
Measured: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Plasma eHSP90 concentration
Change in plasma eHSP90 concentration and return to baseline. Measured via ELISA.
Measured: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Reaction time
Change in reaction time and return to baseline as assessed using ANAM: Automated Neurophysiological Assessment Metrics.
Measured: Pre hot water immersion, then immediately post, 3 hours, 24 hours and 48 hours post
Logical reasoning
Change in logical reasoning and return to baseline as assessed using ANAM: Automated Neurophysiological Assessment Metrics.
Measured: Pre hot water immersion, then immediately post, 3 hours, 24 hours and 48 hours post
Memory
Change in memory function and return to baseline as assessed using ANAM: Automated Neurophysiological Assessment Metrics.
Measured: Pre hot water immersion, then immediately post, 3 hours, 24 hours and 48 hours post
Cerebral oxygenation
Change in cerebral oxygenation and return to baseline. Assessed using Near-infrared spectroscopy (NIRS) attached to the forehead
Measured: Pre hot water immersion, then immediately post, 3 hours, 24 hours and 48 hours post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start23 May 2023
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ant Shepherd, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622747
- Sponsor's protocol ID
- UoPAPHHOA
- Status last verified
- Mar 2025
- First submitted
- 8 Nov 2022
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be anonymized and raw data uploaded to the University of Portsmouth repository.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Time Course of Cardiovascular Function, Cognitive Function and Heat Shock Proteins in Response to Acute Passive Heating in Older Adults
- ClinicalTrials.gov ID
- NCT05622747
- Acronym / sponsor ID
- UoPAPHHOA
- Conditions
- Aging
- Keywords
- Passive heating, Endothelial function, Heat shock proteins, Cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 21 Nov 2022 (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.
Aging is associated with a decline in cardiovascular health, cognitive function and losses in muscle strength, with half or more of those over age 65 suffering from two or more comorbidities (e.g., heart disease, type 2 diabetes). The worldwide population of older adults is growing rapidly, with one in six people expected to be over age 65 by 2050. This will place further financial burden from chronic diseases on already stressed healthcare systems. While studies show that frequent exercise is an effective way for older adults to maintain or improve cardiovascular and metabolic health, older individuals are less physically active and do not adhere well to exercise programs, often due to physical or medical limitations. Therefore, alternative methods for older adults to get the same health benefits as exercise require further exploration. Recent work has shown a single session of passive heat therapy could be an alternative way to improve cardiovascular health and cognitive function in various populations, however, the length of time that these benefits last is yet to be explored.
Detailed description
Aging is associated with declines in cardiovascular health and cognitive function as well as chronic inflammation and the development of neurodegenerative conditions such as Alzheimer's and Parkinson's disease. Additionally, ageing results in a loss of muscle size and strength, commonly referred to as sarcopenia, leading to increased risk of falls or adverse exercise-related events. It is well understood that frequent exercise improves cardiovascular and metabolic health whilst lowering the risk of disease and all-cause mortality, acting as a treatment for many different health conditions. Despite the evidence of its efficacy, many individuals struggle with adherence to exercise programmes, particularly older adults and clinical populations, with many individuals within these populations unable to perform exercise due to physical limitations or medical contraindications. With one in six people expected to be over the age of 65 years by 2050 and corresponding increases in non-communicable diseases (e.g., cancer, diabetes, cardiovascular disease) anticipated from this aging population, the development of adjunct treatments or alternatives to exercise to improve general health in older populations is needed.
Recent work has shown one such potential solution could be the use of passive heat therapy (PHT) (e.g., hot water immersion, sauna), which can achieve health benefits comparable to exercise. Acute PHT induces vascular improvements including increased blood flow, reduced blood pressure. and macro- and microvascular dilator function in various populations. Acute PHT has also been shown to increase reaction time, while mixed results have been seen in its effect on executive function in both young and older populations. The mechanisms for these improvements, however, are currently unclear, and may be related to increases in nitric oxide activity or reductions in biomarkers of inflammation.
One potential mechanism for the physiological benefits obtained from PHT is the increase of cytoprotective heat shock proteins (HSP) (specifically HSP27, HSP60, HSP70 and HSP90) intracellularly (i) and extracellularly (e) in response to increases in deep body temperature. Increases in the expression of these HSPs have been shown to play a role in reducing inflammation and protecting the vasculature via increases in endothelial nitric oxide synthase activity. Increased HSP concentrations may also prevent the accumulation of harmful biomarkers in the brain that play a role in cognitive decline and development of neurodegenerative diseases. There is also evidence that increased preoperative levels of both iHSP70 and eHSP70 are correlated with improved postoperative outcomes following cardiac surgery. Aging, however, is associated with a reduction in HSP transcription activity in various tissues, resulting in an impaired heat shock response and development of a pro-inflammatory state.
Previous work using acute hot water immersion has shown mixed results, with various studies showing increases in eHSP70, iHSP70 and iHSP90, while others have reported no change in expression. Heating stimuli applied in these studies has varied in magnitude, duration and whole body or not, and measurements of HSPs have taken place at various time points before, during and after PHT. Therefore, it is possible that upregulation of HSPs may have been missed, as no time course relationship exists between a single bout of PHT and upregulation of HSPs. Additionally, the duration for acute vascular and cognitive benefits from PHT and when function is returned to baseline is yet to be determined. A time course relationship study to determine the peak HSP response to acute passive heat therapy in older adults would provide insight into the relationship between acute changes in vascular or cognitive function and concurrent upregulation of both intracellular and extracellular HSPs, as well as its potential implications for improved surgical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Passive heating intervention | Experimental | Other: Passive heating1 h hot water immersion (to the clavicle, @40°C, rectal temperature ~38.5°C and <39°C) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female age ≥ 55
- Free from cardiometabolic disease
- Body mass index of 18-35 kg/m2
- Receipt of a normal 12-lead ECG approved by the School Independent Medical Officer
- Capacity to understand and provide their written, informed consent to participate in the study protocol
Key exclusion criteria (7 listed)
- Unable to understand or cooperate with the study protocol due to learning difficulties or otherwise
- Any current, or past medical (last five years), history of any cardiovascular, respiratory, cancer, renal, hepatic, gastrointestinal, haematological, lymphatic, neurological, psychiatric, or any other disease or diseases.
- Any regular medication for the last five years (not including acute courses of treatment of less than one month for discrete, resolved conditions).
- Medications that may influence physiological responses to the passive heating intervention Uncontrolled hypertension (≥ 150 mmHg systolic and/or ≥ 90 mmHg diastolic)
- Body mass index of > 35 kg/m2
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 |
|---|---|---|
| Passive heating1 h hot water immersion (to the clavicle, @40°C, rectal temperature ~38.5°C and <39°C) | Other | Passive heating intervention |
Primary outcome
Brachial artery flow-mediated dilation
Time frame: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Percentage change in brachial artery diameter and return to baseline as assessed by ultrasound.
22 secondary outcomes
Brachial and carotid artery blood flow velocity
Time frame: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Carotid vessel diameter
Time frame: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Carotid intima-media thickness
Time frame: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Carotid compliance
Time frame: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Carotid distensibility
Time frame: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Carotid stiffness
Time frame: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Microvascular function
Time frame: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Stroke volume
Time frame: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Total peripheral resistance
Time frame: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Cardiac output
Time frame: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post
Intracellular HSP27 concentration
Time frame: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Intracellular HSP60 concentration
Time frame: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Intracellular HSP70 concentration
Time frame: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Intracellular HSP90 concentration
Time frame: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Plasma eHSP27 concentration
Time frame: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Plasma eHSP60 concentration
Time frame: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Plasma eHSP70 concentration
Time frame: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Plasma eHSP90 concentration
Time frame: Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post
Reaction time
Time frame: Pre hot water immersion, then immediately post, 3 hours, 24 hours and 48 hours post
Logical reasoning
Time frame: Pre hot water immersion, then immediately post, 3 hours, 24 hours and 48 hours post
Memory
Time frame: Pre hot water immersion, then immediately post, 3 hours, 24 hours and 48 hours post
Cerebral oxygenation
Time frame: Pre hot water immersion, then immediately post, 3 hours, 24 hours and 48 hours post
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 6 Aug 2025.
- Individual participant dataSharing planned: Yes. All data will be anonymized and raw data uploaded to the University of Portsmouth repository.
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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 study testing Passive heating in people with Aging, run by University of Portsmouth at 1 site in United Kingdom.
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 5 inclusion and 7 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 6 Aug 2025. 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 Kingdom. 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.
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?
Brachial artery flow-mediated dilation (time frame: Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post). 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 6 Aug 2025.