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Physical InactivityNCT05409404

The Effects of 8 Weeks Post Exercise Hot Water Immersion on Vascular and Cardiometabolic Health in Physically Inactive Middle-aged Adults

A study testing Aerobic exercise + hot water immersion and Aerobic exercise + thermoneutral water immersion in people with Physical Inactivity and Aging, run by Coventry University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Physical Inactivity, Aging
What is being tested?
Aerobic exercise + hot water immersion and Aerobic exercise + thermoneutral water immersion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited Kingdom
Study dates
13 Jan 2023to 25 Aug 2023
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 45 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Coventry University

    Coventry, West Midlands, CV1 5FB

Other trials in United Kingdom

About this study

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).

Read the 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.

Being tested
Aerobic exercise + hot water immersion, Aerobic exercise + thermoneutral water immersion
Medical subject headings
Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic exercise + hot water immersionOther

    Light to moderate intensity aerobic exercise for 30 minutes, followed by 30 minutes of hot water immersion at 40°C.

  • Aerobic exercise + thermoneutral water immersionOther

    Light to moderate intensity aerobic exercise for 30 minutes, followed by 30 minutes of thermoneutral water immersion at 34°C.

Study groups in NCT05409404
Study groupRoleWhat they receive
Aerobic exercise + hot water immersionExperimental3 sessions per week, over an 8 week period, with each session consisting of 30 minutes of aerobic exercise (10 minutes cycling, jogging and rowing) at a power output equivalent to 65-75% of maximal heart rate followed by 30 minutes of whole body hot water immersion at 40°C.
Receives: Other: Aerobic exercise + hot water immersion
Aerobic exercise + thermoneutral water immersionActive comparator3 sessions per week, over an 8 week period, with each session consisting of 30 minutes of aerobic exercise (10 minutes cycling, jogging and rowing) at a power output equivalent to 65-75% of maximal heart rate followed by 30 minutes of whole body water immersion at 34°C.
Receives: Other: Aerobic exercise + thermoneutral water immersion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in resting systolic blood pressure (mmHg)

    Measured using an automated blood pressure cuff

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  2. Change in resting diastolic blood pressure (mmHg)

    Measured using an automated blood pressure cuff

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  3. Change in resting mean arterial blood pressure (mmHg)

    Measured using an automated blood pressure cuff

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  4. Change in flow mediated dilation (%)

    Terason ultrasound recording after brachial artery occlusion

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  5. Change in pulse wave velocity (ms-1)

    SphygmoCor XCEL measuring carotid to femoral arterial stiffness

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  6. Change in intima-media thickness (mm)

    Terason ultrasound image to measure wall thickness from the lumen-intima interface to the media-adventitia interface of the brachial and femoral arteries

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  7. Change in beta stifnness index

    Calculated using systolic, diastolic blood pressure from automated blood pressure cuff and vessel diameter from Terason ultrasound image of brachial and femoral arteries

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  8. Change in dynamic arterial compliance (mm2)

    Calculated using pulse pressure from automated blood pressure cuff and vessel diameter from Terasol ultrasound image of brachial and femoral arteries

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  9. Change in maximal oxygen uptake (ml/kg/min)

    Maximal oxygen uptake

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  10. Change in glucose tolerance (mmol/L)

    Oral glucose tolerance test through fingertip capillary blood samples at 15 minute intervals for the first 1 hour and 30 minute intervals for the second hour

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  11. Change in circulating serum Interleukin-6 (pg/ml)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  12. Change in circulating serum TNF-α (pg/ml)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  13. Change in circulating serum Interleukin-8 (pg/ml)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  14. Change in circulating serum Interleukin-10 (pg/ml)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  15. Change in circulating serum Interleukin-1Ra (pg/ml)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  16. Change in circulating Endothelin-1 (pg/ml)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  17. Circulating serum Monocyte chemoattractant protein-1 (pg/ml)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  18. Change in circulating serum Matrix metallopeptidase-2 (pg/ml)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  19. Change in circulating serum Matrix metallopeptidase-9 (pg/ml)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  20. Change in circulating total cholesterol (mmol/L)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  21. Change in circulating low density lipoproteins (mmol/L)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  22. Change in circulating high density lipoproteins (mmol/L)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  23. Change in circulating Triglycerides (mmol/L)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  24. Change in circulating glycated haemoglobin (%)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  25. Change in circulating basal glucose (mmol/L)

    Venous blood sample

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

Secondary outcomes (8)
  1. Change in Framingham risk score

    Calculation based on age, gender, total cholesterol, HDL cholesterol, smoker, diabetes status and systolic blood pressure

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  2. Change in rectal core temperature (°C)

    Measured using a rectal probe attached to a squirrel data logger

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  3. Change in resting heart rate (bpm)

    Measured using a heart rate monitor

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  4. Body mass index (kg/m²)

    Calculated through height and weight

    Measured: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

  5. Change in thermal comfort

    Thermal comfort Likert scale from a positive score of +5 very comfortable (maximum) to a negative score of -5 very uncomfortable (minimum)

    Measured: Measurements taken pre and post visit 1, 12 (4 weeks) and 24 (8 weeks)

  6. Change in thermal sensation

    Thermal sensation Likert scale from a positive score of +5 hot (maximum) to a negative score of -5 cold (minimum)

    Measured: Measurements taken pre and post visit 1, 12 (4 weeks) and 24 (8 weeks)

  7. Change in basic affect

    Basic affect Likert scale from a positive score of +5 very good (maximum) to a negative score of -5 very bad (minimum)

    Measured: Measurements taken pre and post visit 1, 12 (4 weeks) and 24 (8 weeks)

  8. Change in physical activity enjoyment

    Feelings about exercise and / or passive heating on a Likert scale from a positive score of 1 (maximum) to a negative score of 7 (minimum)

    Measured: Measurements taken pre and post visit 1, 12 (4 weeks) and 24 (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study start13 Jan 2023
  3. Primary completion25 Aug 2023
  4. Study completion25 Aug 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05409404
Sponsor's protocol ID
P132234
Status last verified
Oct 2023
First submitted
18 Mar 2022
Last updated
24 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with other researchers. Data will be used to publish research articles in academic journals with all data fully anonymised.

Publications

  • Steward CJ, Hill M, Menzies C, Russell SL, Thake CD, Pugh CJA, Cullen T. Post-exercise hot water immersion enhances haemodynamic and vascular benefits of exercise without further improving cardiorespiratory fitness, glucose, lipids or inflammation. J Physiol. 2025 Aug;603(16):4515-4533. doi: 10.1113/JP288873. Epub 2025 Jul 28.

    PubMed 40719540

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic exercise + hot water immersion and Aerobic exercise + thermoneutral water immersion in people with Physical Inactivity and Aging, run by Coventry University 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 4 inclusion and 17 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 24 Oct 2023. 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?

Change in resting systolic blood pressure (mmHg) (time frame: Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05409404, which also lists 1 linked publication.

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 24 Oct 2023.

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