Clinical trial NCT05409404: The Effects of 8 Weeks Post Exercise Hot Water Immersion on Vascular and Cardiometabolic Health in Physically Inactive Middle-aged Adults
Official title: The Effects of 8 Weeks Post Exercise Hot Water Immersion on Vascular and Cardiometabolic Health in Physically Inactive Middle-aged Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Aging
Lead sponsor: Coventry University
Sponsor class: OTHER
Collaborators: name: British Society for Research on Ageing
First posted: 2022-06-08
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research project aims to determine whether post exercise hot water immersion can improve vascular and cardiometabolic health to a greater extent than post exercise thermoneutral water immersion in healthy middle-aged adults.

The study will take place over an 8 week period where participants will do a combination of aerobic exercise and water immersion 3 times per week. The study will be a randomised controlled trial comparing 8-weeks of post exercise hot water immersion (EX+HWI) to post exercise thermoneutral water immersion (EX+TNWI).

Detailed description: The exercise component of each intervention will be 30 minutes of moderate intensity aerobic exercise consisting of 10 minutes cycling, jogging and rowing, three times per week. Exercise intensity will be maintained at a heart rate equivalent of 65% of maximal heart rate. All exercise sessions will take the form of supervised group exercise sessions (\<4 participants) at Coventry University. After 30 minutes of exercise, participants will either complete 30 minutes of whole-body hot water immersion at 40°C or thermoneutral immersion at 34°C in the control condition (similar protocols are known to be well tolerated in older adults) (Akerman et al. 2019; Brunt et al. 2016). In order to ensure progression, exercise intensity will be increase to 75% of maximal heart rate according to the maximal exercise test at 4 weeks.

Assessment sessions will take place before session 1 and \>48hrs after session 12 and 24. Prior to arriving at the lab participants will complete an overnight fast. Participants will also refrain from consuming alcoholic and caffeinated beverages, nitrate high sources and any form of strenuous exercise in the 24hr time period prior to testing. All testing laboratory visits will be completed in the morning and where possible at the same time of day to help standardise for any potential variations that the circadian rhythm may have on the measured variables.

Assessments will be completed over two days. The outcome measures for this study comprise a range of physiological psychological measures which are known to inform the risk of cardiovascular disease. These measures fall into the following broad categories 1) vascular health; 2) cardiometabolic and inflammatory blood markers; 3) maximal exercise test and 4) cardiovascular disease risk prediction. In addition, measures of intervention acceptability and basic physiological heat acclimation measures will also be assessed.

Eligibility criteria: Inclusion Criteria:

* Aged between 45 - 65 years
* If female and post-menopausal (12 months without a period and not taking HRT)
* Body mass index (BMI) 18.5 - 34.9kg/m2
* Participated in less than 150 mins of moderate intensity physical activity or 75 mins of vigorous or a combination of both over the last 6 months.

Exclusion Criteria:

* Previous myocardial infarction or cerebrovascular event
* Any signs or symptoms of cardiovascular issues
* High blood pressure: SBP \>180 mmHg and / or DBP \>100 mmHg
* Orthostatic hypotension: Drop of SBP \> 20mmHg and / or DBP \>10 mmHg upon standing.
* Changed blood pressure medication in the 6-month period prior to the study
* Plan to change any form of relevant medication during study period
* Suffers from diabetes
* Suffers from severe asthma
* Currently have any infections or symptoms of an infection (e.g. COVID-19 etc)
* Suffers from a neurodegenerative disease
* Cannot understand and/or fully cooperate with the study protocol
* Exercise-limiting comorbidity (e.g. angina, chronic lung disease, arthritis etc)
* Severe peripheral neuropathy (cannot sense temperature)
* Current smoker or have stopped in the last 3 months
* Any skin conditions including ulcerations
* Exposed to high temperatures in the last 4-weeks (e.g. holiday, spa, sun beds etc)
* Use of antioxidant supplements in the last 6-weeks

Primary outcomes:
measure: Change in resting systolic blood pressure (mmHg)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in resting diastolic blood pressure (mmHg)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in resting mean arterial blood pressure (mmHg)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in flow mediated dilation (%)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in pulse wave velocity (ms-1)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in intima-media thickness (mm)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in beta stifnness index
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in dynamic arterial compliance (mm2)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in maximal oxygen uptake (ml/kg/min)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in glucose tolerance (mmol/L)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating serum Interleukin-6 (pg/ml)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating serum TNF-α (pg/ml)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating serum Interleukin-8 (pg/ml)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating serum Interleukin-10 (pg/ml)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating serum Interleukin-1Ra (pg/ml)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating Endothelin-1 (pg/ml)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Circulating serum Monocyte chemoattractant protein-1 (pg/ml)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating serum Matrix metallopeptidase-2 (pg/ml)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating serum Matrix metallopeptidase-9 (pg/ml)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating total cholesterol (mmol/L)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating low density lipoproteins (mmol/L)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating high density lipoproteins (mmol/L)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating Triglycerides (mmol/L)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating glycated haemoglobin (%)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in circulating basal glucose (mmol/L)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
Secondary outcomes:
measure: Change in Framingham risk score
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in rectal core temperature (°C)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in resting heart rate (bpm)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Body mass index (kg/m²)
timeFrame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks
measure: Change in thermal comfort
timeFrame: Measurements taken pre and post visit 1, 12 (4 weeks) and 24 (8 weeks)
measure: Change in thermal sensation
timeFrame: Measurements taken pre and post visit 1, 12 (4 weeks) and 24 (8 weeks)
measure: Change in basic affect
timeFrame: Measurements taken pre and post visit 1, 12 (4 weeks) and 24 (8 weeks)
measure: Change in physical activity enjoyment
timeFrame: Measurements taken pre and post visit 1, 12 (4 weeks) and 24 (8 weeks)
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: Coventry University
state: West Midlands
Study officials:
References: