Aging Clinical Trial
Official title:
The Time Course of Cardiovascular Function, Cognitive Function and Heat Shock Proteins in Response to Acute Passive Heating in Older Adults
NCT number | NCT05622747 |
Other study ID # | UoPAPHHOA |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 23, 2023 |
Est. completion date | May 2025 |
Verified date | February 2024 |
Source | University of Portsmouth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Spinnaker Building | Portsmouth | Hampshire |
Lead Sponsor | Collaborator |
---|---|
University of Portsmouth |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brachial artery flow-mediated dilation | Percentage change in brachial artery diameter and return to baseline as assessed by ultrasound. | Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post | |
Secondary | 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. | Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post | |
Secondary | 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. | Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post | |
Secondary | 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. | Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post | |
Secondary | 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. | Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post | |
Secondary | 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. | Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post | |
Secondary | 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. | Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post | |
Secondary | 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. | Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post | |
Secondary | Stroke volume | Change in stroke volume and return to baseline measured noninvasively via thoracic impedance. mL/m^2 is the unit | Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post | |
Secondary | Total peripheral resistance | Change in total peripheral resistance and return to baseline measured noninvasively via thoracic impedance | Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post | |
Secondary | Cardiac output | Change in cardiac output and return to baseline measured noninvasively via thoracic impedance. L/min is the unit. | Pre hot water immersion, then 1 hour, 3 hours, 24 hours and 48 hours post | |
Secondary | Intracellular HSP27 concentration | Change in iHSP27 concentration and return to baseline. Measured via immunoblotting in peripheral blood mononuclear cells (PBMCs). | Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post | |
Secondary | Intracellular HSP60 concentration | Change in iHSP60 concentration and return to baseline. Measured via immunoblotting in peripheral blood mononuclear cells (PBMCs). | Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post | |
Secondary | Intracellular HSP70 concentration | Change in iHSP70 concentration and return to baseline. Measured via immunoblotting in peripheral blood mononuclear cells (PBMCs). | Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post | |
Secondary | Intracellular HSP90 concentration | Change in iHSP90 concentration and return to baseline. Measured via immunoblotting in peripheral blood mononuclear cells (PBMCs). | Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post | |
Secondary | Plasma eHSP27 concentration | Change in plasma eHSP27 concentration and return to baseline. Measured via ELISA. | Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post | |
Secondary | Plasma eHSP60 concentration | Change in plasma eHSP60 concentration and return to baseline. Measured via ELISA. | Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post | |
Secondary | Plasma eHSP70 concentration | Change in plasma eHSP70 concentration and return to baseline. Measured via ELISA. | Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post | |
Secondary | Plasma eHSP90 concentration | Change in plasma eHSP90 concentration and return to baseline. Measured via ELISA. | Pre hot water immersion, then immediately post, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours post | |
Secondary | Reaction time | Change in reaction time and return to baseline as assessed using ANAM: Automated Neurophysiological Assessment Metrics. | Pre hot water immersion, then immediately post, 3 hours, 24 hours and 48 hours post | |
Secondary | Logical reasoning | Change in logical reasoning and return to baseline as assessed using ANAM: Automated Neurophysiological Assessment Metrics. | Pre hot water immersion, then immediately post, 3 hours, 24 hours and 48 hours post | |
Secondary | Memory | Change in memory function and return to baseline as assessed using ANAM: Automated Neurophysiological Assessment Metrics. | Pre hot water immersion, then immediately post, 3 hours, 24 hours and 48 hours post | |
Secondary | Cerebral oxygenation | Change in cerebral oxygenation and return to baseline. Assessed using Near-infrared spectroscopy (NIRS) attached to the forehead | Pre hot water immersion, then immediately post, 3 hours, 24 hours and 48 hours post |
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