- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05727774
Effect of Water Biking in Hot Versus Neutral Water for Heat Acclimatation (THERMIDOR)
Effect of Hot Versus Neutral Water for Heat Acclimatation and Sport Performance During a Water Biking Training Protocol : Controlled Randomised Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this clinical trial is to compare the efficiency of water biking training in hot (35°C) versus neutral (25°C) temperature water to elicite heat acclimation in healthy recreative athletes. The main questions it aims to answer are:
- Does the water biking training protocol in hot versus neutral temperature water improve the time trial in an artificially hot and humid indoor environment?
- Does the water biking training protocol in hot versus neutral temperature water improve the VO2 max performance and force/velocity profile in neutral indoor environment?
- What are the main acclimation adaptations (central and cutaneous temperature), heart rate, cardiac function, sweating quality, sleep quality, haematologic profile.
Participants will have to do pre and post training tests in both normal environment (cardiorespiratory stress test, force/velocity profile test, echocardiography) and artificially hot and humid indoor environment (time trial). The training protocols consists in 10 sessions of 1 hour of water bike aerobic training (5 times a week for 2 weeks) at an intensity based on the heart rate corresponding to the 1st respiratory threshold, in hot (interventional group IG: 35°C) versus neutral (control group CG: 25°C) water.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- Département de Médecine Physique et Réadaptation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy people
- Sports practicing
Exclusion Criteria:
- Acclimatation already done (recent training in hot and/or humid) less than 2 months
- Heart disease recent or non controlled
- Heat intolerance
- Water phobia or inable to swim
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Hot water condition
Participants do the water biking training for two weeks, 1 hour a day, in hot water temperature (35°C)
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Training protocol includes 10 water biking sessions in hot water temperature (35°C) for this group
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Sham Comparator: Neutral water condition
Participants do the water biking training for two weeks, 1 hour a day, in neutral water temperature (25°C)
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Training protocol includes 10 water biking sessions in neutral water temperature (25°C) for this group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of the distance traveled (meter) on a Time Trial between pre and post training tests in hot and humid atmosphere (environmental room)
Time Frame: The 1st Time Trial will be performed the week preceding the program training. The 2nd Time Trial will be performed the week following the program training
|
The participant has to perform the longer distance possible in 30 min on a stationary bike in hot and humid atmosphere (environmental room).
The change of distance (measured in meter) will be assessed before and after the 2 weeks training program.
|
The 1st Time Trial will be performed the week preceding the program training. The 2nd Time Trial will be performed the week following the program training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in VO2 Max (ml/kg/min) between pre and post training tests in normal environment
Time Frame: The 1st maximal cardiorespiratory test will be performed the week preceding the program training. The 2nd maximal cardiorespiratory test will be performed the week following the program training
|
The participant has to perform a maximal cardiorespiratory test on a stationary bike in normal environment.
The change in VO2 Max (measured in ml/kg/min) will be assessed before and after the 2 weeks training program.
|
The 1st maximal cardiorespiratory test will be performed the week preceding the program training. The 2nd maximal cardiorespiratory test will be performed the week following the program training
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|
Change in Maximal Aerobic Power (Watts) between pre and post training tests in normal environment
Time Frame: The 1st maximal cardiorespiratory test will be performed the week preceding the program training. The 2nd maximal cardiorespiratory test will be performed the week following the program training
|
The participant has to perform a maximal cardiorespiratory test on a stationary bike in normal environment.
The change in Maximal Aerobic Power (measured in Watts) will be assessed before and after the 2 weeks training program.
|
The 1st maximal cardiorespiratory test will be performed the week preceding the program training. The 2nd maximal cardiorespiratory test will be performed the week following the program training
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Change of "global longitudinal strain of left ventricule" (%) measured during an echocardiography between pre and post training tests in normal environment
Time Frame: The 1st echocardiography will be performed the week preceding the program training. The 2nd echocardiography will be performed the week following the program training
|
The participant has to pass an echocardiography with specific measurment of "global longitudinal strain of left ventricule" (united in %).
The change will be assessed before and after the 2 weeks training program.
|
The 1st echocardiography will be performed the week preceding the program training. The 2nd echocardiography will be performed the week following the program training
|
|
Change on central temperature (°C) between pre and post training test in hot and humid atmosphere (environmental room)
Time Frame: The 1st Time Trial will be performed the week preceding the program training. The 2nd Time Trial will be performed the week following the program training
|
Central temperature will be measured during Time Trial in hot and humid atmosphere (environmental room).
The change on central temperature (measured in °C) will be assessed before and after the 2 weeks training program.
|
The 1st Time Trial will be performed the week preceding the program training. The 2nd Time Trial will be performed the week following the program training
|
|
Change on cutaneours temperature (°C) between pre and post training test in hot and humid atmosphere (environmental room)
Time Frame: The 1st Time Trial will be performed the week preceding the program training. The 2nd Time Trial will be performed the week following the program training
|
Cutaneous temperature will be measured during Time Trial in hot and humid atmosphere (environmental room).
The change on cutaneours temperature (measured in °C) will be assessed before and after the 2 weeks training program.
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The 1st Time Trial will be performed the week preceding the program training. The 2nd Time Trial will be performed the week following the program training
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Change of Na concentration (mmol/L) in the sweat between pre and post training test in hot and humid atmosphere (environmental room)
Time Frame: The 1st Time Trial will be performed the week preceding the program training. The 2nd Time Trial will be performed the week following the program training
|
Sweat quality will be measured during Time Trial in hot and humid atmosphere (environmental room).
The change of Na concentration (measured in mmol/l) will be assessed before and after the 2 weeks training program.
|
The 1st Time Trial will be performed the week preceding the program training. The 2nd Time Trial will be performed the week following the program training
|
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Change of body weight loss (Kg) between pre and post training test in hot and humid atmosphere (environmental room)
Time Frame: The 1st measure of body weight will be performed the week preceding the program training. The 2nd measure of body weight will be performed the week following the program training
|
Body weight loss will be measured before and after Time Trial in hot and humid atmosphere (environmental room).
The change of the body weight (measured in Kg) will be assessed between before and after the 2 weeks training program.
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The 1st measure of body weight will be performed the week preceding the program training. The 2nd measure of body weight will be performed the week following the program training
|
|
Change of Sleep quality between the first and the last training session of water biking
Time Frame: The sleep self-questionnaire will be performed immediately after the first training session (Day 1) and immediately after the last training session (Day 10) of water biking
|
Sleep quality will be measured after the first and the last training session using a specific sleep self-questionnaire (PSQI) to detect the effect of hot or neutral water training during the 2 weeks training program. PSQI : Pittsburgh Sleep Quality Index. Qualitative questionnaire, no score measured. |
The sleep self-questionnaire will be performed immediately after the first training session (Day 1) and immediately after the last training session (Day 10) of water biking
|
|
Change of force/velocity power (N/m) between pre and post training test
Time Frame: The 1st measure of force/velocity power will be performed the week preceding the program training. The 2nd measure of force/velocity power will be performed the week following the program training
|
The participant has to perform a maximal force/velocity test to measure the force/velocity power on a specific fitness testing cycle (Monark 818 E).
The change of force/velocity power (measured in N/m) will be assessed between before and after the 2 weeks training program.
|
The 1st measure of force/velocity power will be performed the week preceding the program training. The 2nd measure of force/velocity power will be performed the week following the program training
|
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Change of sytemic low grade inflammation (CRP = C-Reactive Protein, mg/l) between pre and post training test
Time Frame: The 1st measure of CRP will be performed the week preceding the program training. The 2nd measure of CRP will be performed the week following the program training
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A blood test will be performed to measure the change of CRP concentration (measured in mg/l) between before and after the 2 weeks training program.
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The 1st measure of CRP will be performed the week preceding the program training. The 2nd measure of CRP will be performed the week following the program training
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Change of haematocrit (%) between pre and post training test
Time Frame: The 1st measure of haematocrit will be performed the week preceding the program training. The 2nd measure of haematocrit will be performed the week following the program training
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A blood test with complete blood count will be performed to measure the change of haematocrit (which is expressed in %) between before and after the 2 weeks training program.
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The 1st measure of haematocrit will be performed the week preceding the program training. The 2nd measure of haematocrit will be performed the week following the program training
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Change of hemoglobin level (g/100ml) between pre and post training test
Time Frame: The 1st measure of hemoglobin level will be performed the week preceding the program training. The 2nd measure of hemoglobin level will be performed the week following the program training
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A blood test with complete blood count will be performed to measure the change of hemoglobin level (measured in g/100ml) between before and after the 2 weeks training program.
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The 1st measure of hemoglobin level will be performed the week preceding the program training. The 2nd measure of hemoglobin level will be performed the week following the program training
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Change of Rate of Perceived Effort (RPE) on a Time Trial between pre and post training tests
Time Frame: The 1st Time Trial will be performed the week preceding the program training. The 2nd Time Trial will be performed the week following the program training
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The Borg Rating of Perceived Exertion (RPE) will be used to measure physical activity intensity level. The scale is from 6 to 20. The higher the score is, the higher the perception of effort is. RPE will be measured after the first Time Trial and after the second Time Trial (post training protocol). |
The 1st Time Trial will be performed the week preceding the program training. The 2nd Time Trial will be performed the week following the program training
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Periard JD, Travers GJS, Racinais S, Sawka MN. Cardiovascular adaptations supporting human exercise-heat acclimation. Auton Neurosci. 2016 Apr;196:52-62. doi: 10.1016/j.autneu.2016.02.002. Epub 2016 Feb 12.
- Kelly M, Gastin PB, Dwyer DB, Sostaric S, Snow RJ. Short Duration Heat Acclimation in Australian Football Players. J Sports Sci Med. 2016 Feb 23;15(1):118-25. eCollection 2016 Mar.
- Zurawlew MJ, Walsh NP, Fortes MB, Potter C. Post-exercise hot water immersion induces heat acclimation and improves endurance exercise performance in the heat. Scand J Med Sci Sports. 2016 Jul;26(7):745-54. doi: 10.1111/sms.12638. Epub 2015 Dec 9.
- Zurawlew MJ, Mee JA, Walsh NP. Post-exercise Hot Water Immersion Elicits Heat Acclimation Adaptations in Endurance Trained and Recreationally Active Individuals. Front Physiol. 2018 Dec 18;9:1824. doi: 10.3389/fphys.2018.01824. eCollection 2018.
- Racinais S, Alonso JM, Coutts AJ, Flouris AD, Girard O, Gonzalez-Alonso J, Hausswirth C, Jay O, Lee JK, Mitchell N, Nassis GP, Nybo L, Pluim BM, Roelands B, Sawka MN, Wingo J, Periard JD. Consensus recommendations on training and competing in the heat. Br J Sports Med. 2015 Sep;49(18):1164-73. doi: 10.1136/bjsports-2015-094915. Epub 2015 Jun 11.
- Zurawlew MJ, Mee JA, Walsh NP. Post-exercise Hot Water Immersion Elicits Heat Acclimation Adaptations That Are Retained for at Least Two Weeks. Front Physiol. 2019 Aug 28;10:1080. doi: 10.3389/fphys.2019.01080. eCollection 2019.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RECHMPL22_0076
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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