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CompletedNCT05409404Updated Oct 24, 2023

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

An interventional study of Aerobic exercise + hot water immersion and Aerobic exercise + thermoneutral water immersion in Physical Inactivity and Aging, sponsored by Coventry University. Completed at 1 site in United Kingdom. Open to participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-24.

Sponsored by Coventry University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Physical Inactivity
  • Aging
03

In context

Lead sponsor

Coventry University is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Aerobic exercise + hot water immersion

    3 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.

    Other: Aerobic exercise + hot water immersion

  • Active comparator
    Aerobic exercise + thermoneutral water immersion

    3 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.

    Other: Aerobic exercise + thermoneutral water immersion

Interventions

  • OtherAerobic exercise + hot water immersion

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

  • OtherAerobic exercise + thermoneutral water immersion

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

06

What researchers measure

Primary outcomes

  1. Change in resting systolic blood pressure (mmHg)

    Measured using an automated blood pressure cuff

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Secondary outcomes

  1. Change in Framingham risk score

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

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

07

Study locations

1 site
  • Coventry University
    Coventry, West Midlands CV1 5FB, United Kingdom
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05409404
Lead sponsor
Coventry University
Collaborators
British Society for Research on Ageing
Responsible party
Charles Steward (Post Graduate Research Student, Coventry University) — Principal investigator
First posted
Jun 8, 2022
Start date
Jan 13, 2023
Primary completion
Aug 25, 2023
Completion
Aug 25, 2023
Last update
Oct 24, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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