- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06672614
Postexercise Hot-Water Immersion on Exercise Performance in Hypoxia
November 1, 2024 updated by: Geoff Hartley, Nipissing University
Effect of Five Days of Postexercise Hot-Water Immersion on Exercise Performance in Hypoxia
The purpose of this study is to determine the effect of 5 days post-exercise hot water immersion on exercise performance at simulated altitude.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Human performance is compromised at altitude due to a lower partial pressure of oxygen and subsequent reductions in the convective transport of oxygen to tissue.
Long-term acclimation to attitude incurs physiological adaptations that result in a near return to sea-level performance; however, the time required (~2 weeks) for such adaptations is often logistically challenging for athletes, military personnel or other individuals who reside at sea level.
Recent research suggests that physiological acclimation to heat stress (i.e., heat acclimation) and altitude (i.e., hypoxia) share similar cellular adaptations, namely an up-regulation of Hypoxia-inducible factor 1 (HIF-1) and various heat shock proteins.
Therefore, it is hypothesized that heat acclimation may provide physiological protection from reduced oxygen transport to the tissue and enhance performance at altitude.
This cross-tolerance model is supported by traditional heat acclimation protocols (i.e., submaximal exercise in hot ambient temperature); however, it has not been tested with passive exposure to heat stress through post-exercise hot water immersion.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Geoffrey L Hartley, PhD
- Phone Number: 705 845-3887
- Email: geoffh@nipissingu.ca
Study Locations
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Ontario
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North Bay, Ontario, Canada, P1B 8L7
- Nipissing University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Physically active (minimum of 90 minutes of moderate-intensity exercise per week)
Exclusion Criteria:
- Cardiovascular disease
- resident of >1500 m above sea-level in the past year;
- history of fainting
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Post-Exercise Hot Water Immersion
Participants will cycle for 60 minutes at 50% of maximal oxygen uptake (VO2 max) followed by 30 minutes post-exercise hot water immersion (40oC) for 5 consecutive days.
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Participants will cycle for 60 minutes at 50% of maximal oxygen uptake (VO2 max) followed by 30 minutes post-exercise hot water immersion (40oC) for 5 consecutive days.
|
|
Active Comparator: Control group
Participants will cycle for 60 minutes at 50% of maximal oxygen uptake (VO2 max); however, there will be not water immersion following exercise.
|
Participants will cycle for 60 minutes at 50% maximal oxygen uptake (VO2 max) for 5 consecutive days.
There is no water immersion following the exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time-Trial Performance in hypoxia conditions
Time Frame: 30 minutes
|
Results of a 16 km time-trial test conducted at an fraction of inspired oxygen (FiO2) of 0.14
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulse oxygen saturation during exercise
Time Frame: 30 minutes
|
Capillary oxygen saturation measured on the earlobe throughout the time-trial tests using pulse oximetry.
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30 minutes
|
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Skin temperature during exercise
Time Frame: 90 minutes
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Skin temperature measured throughout the time trial-tests and exercise training intervention using temperature probes attached to the calf, thigh, chest and arm, from which weighted averages are calculated.
|
90 minutes
|
|
Core temperature during exercise
Time Frame: 90 minutes
|
Core body temperature measured throughout the time-trial tests and exercise training interventions using a rectal temperature probe.
|
90 minutes
|
|
Heart Rate during exercise
Time Frame: 90 minutes
|
Heart rate will be measured throughout the time trial tests and exercise training interventions using a wireless (Polar) heart rate chest strap.
|
90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Geoffrey L Hartley, PhD, Nipissing University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2024
Primary Completion (Estimated)
October 31, 2025
Study Completion (Estimated)
October 31, 2025
Study Registration Dates
First Submitted
October 30, 2024
First Submitted That Met QC Criteria
November 1, 2024
First Posted (Estimated)
November 4, 2024
Study Record Updates
Last Update Posted (Estimated)
November 4, 2024
Last Update Submitted That Met QC Criteria
November 1, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUREB # 103807
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All of the individual participant data collected during the study, after de-identification, will be made publicly available using an online data repository.
IPD Sharing Time Frame
Data will be made available immediately following publication with no end date.
IPD Sharing Access Criteria
Any purpose.
IPD Sharing Supporting Information Type
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.