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Completed

NCT Number: NCT05409404

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

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).

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coventry University

Coventry, West Midlands, CV1 5FB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic exercise + hot water immersion

Other

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

Aerobic exercise + thermoneutral water immersion

Other

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

Primary outcomes

  1. 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

    Measured using an automated blood pressure cuff

  2. Change in resting diastolic blood pressure (mmHg)

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

    Measured using an automated blood pressure cuff

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

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

    Measured using an automated blood pressure cuff

  4. Change in flow mediated dilation (%)

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

    Terason ultrasound recording after brachial artery occlusion

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

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

    SphygmoCor XCEL measuring carotid to femoral arterial stiffness

  6. Change in intima-media thickness (mm)

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

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

  7. Change in beta stifnness index

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

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

  8. Change in dynamic arterial compliance (mm2)

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

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

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

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

    Maximal oxygen uptake

  10. Change in glucose tolerance (mmol/L)

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

    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

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

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

    Venous blood sample

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

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

    Venous blood sample

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

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

    Venous blood sample

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

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

    Venous blood sample

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

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

    Venous blood sample

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

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

    Venous blood sample

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

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

    Venous blood sample

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

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

    Venous blood sample

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

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

    Venous blood sample

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

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

    Venous blood sample

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

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

    Venous blood sample

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

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

    Venous blood sample

  23. Change in circulating Triglycerides (mmol/L)

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

    Venous blood sample

  24. Change in circulating glycated haemoglobin (%)

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

    Venous blood sample

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

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

    Venous blood sample

Secondary outcomes

  1. Change in Framingham risk score

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

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

  2. Change in rectal core temperature (°C)

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

    Measured using a rectal probe attached to a squirrel data logger

  3. Change in resting heart rate (bpm)

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

    Measured using a heart rate monitor

  4. Body mass index (kg/m²)

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

    Calculated through height and weight

  5. Change in thermal comfort

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

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

  6. Change in thermal sensation

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

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

  7. Change in basic affect

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

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

  8. Change in physical activity enjoyment

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

    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)

Sponsors and collaborators

Lead sponsor

Coventry University

Other

Collaborators

  • British Society for Research on Ageing

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2022
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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