Heat ExposureNCT06672614
Postexercise Hot-Water Immersion on Exercise Performance in Hypoxia
A study testing Post-Exercise Hot Water Immersion in people with Heat Exposure and Exercise Training, run by Nipissing University at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effect of 5 days post-exercise hot water immersion on exercise performance at simulated altitude. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Exposure, Exercise Training
- What is being tested?
- Post-Exercise Hot Water Immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically active (minimum of 90 minutes of moderate-intensity exercise per week)
Who cannot join
- Cardiovascular disease
- resident of >1500 m above sea-level in the past year;
- history of fainting
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heat Exposure, Exercise Training
- Being tested
- Post-Exercise Hot Water Immersion, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-Exercise Hot Water ImmersionOther
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.
Control GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Post-Exercise Hot Water Immersion | Experimental | 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. Receives: Other: Post-Exercise Hot Water Immersion |
| Control group | Active comparator | Participants will cycle for 60 minutes at 50% of maximal oxygen uptake (VO2 max); however, there will be not water immersion following exercise. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-Trial Performance in hypoxia conditions
Results of a 16 km time-trial test conducted at an fraction of inspired oxygen (FiO2) of 0.14
Measured: 30 minutes
Secondary outcomes (4)
Pulse oxygen saturation during exercise
Capillary oxygen saturation measured on the earlobe throughout the time-trial tests using pulse oximetry.
Measured: 30 minutes
Skin temperature during exercise
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.
Measured: 90 minutes
Core temperature during exercise
Core body temperature measured throughout the time-trial tests and exercise training interventions using a rectal temperature probe.
Measured: 90 minutes
Heart Rate during exercise
Heart rate will be measured throughout the time trial tests and exercise training interventions using a wireless (Polar) heart rate chest strap.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nipissing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoff Hartley, Nipissing University
- Investigators
- Geoffrey L Hartley, PhD, Principal investigator, Nipissing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672614
- Sponsor's protocol ID
- NUREB # 103807
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the study, after de-identification, will be made publicly available using an online data repository.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Five Days of Postexercise Hot-Water Immersion on Exercise Performance in Hypoxia
- ClinicalTrials.gov ID
- NCT06672614
- Acronym / sponsor ID
- NUREB # 103807
- Conditions
- Heat Exposure, Exercise Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nipissing UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of 5 days post-exercise hot water immersion on exercise performance at simulated altitude.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-Exercise Hot Water Immersion | Experimental | Other: Post-Exercise Hot Water ImmersionParticipants 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. |
| Control group | Active comparator | Other: Control GroupParticipants will cycle for 60 minutes at 50% of maximal oxygen uptake (VO2 max); however, there will be not water immersion following exercise. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Physically active (minimum of 90 minutes of moderate-intensity exercise per week)
Key exclusion criteria (3 listed)
- Cardiovascular disease
- resident of >1500 m above sea-level in the past year;
- history of fainting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-Exercise Hot Water ImmersionParticipants 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. | Other | Post-Exercise Hot Water Immersion |
| Control GroupParticipants will cycle for 60 minutes at 50% maximal oxygen uptake (VO2 max) for 5 consecutive days. There is no water immersion following the exercise. | Other | Control group |
Primary outcome
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
4 secondary outcomes
Pulse oxygen saturation during exercise
Time frame: 30 minutes
Skin temperature during exercise
Time frame: 90 minutes
Core temperature during exercise
Time frame: 90 minutes
Heart Rate during exercise
Time frame: 90 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the study, after de-identification, will be made publicly available using an online data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Geoffrey L Hartley, PhD principal investigator
Nipissing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-Exercise Hot Water Immersion in people with Heat Exposure and Exercise Training, run by Nipissing University at 1 site in Canada.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 4 Nov 2024. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geoffrey L Hartley, PhD (705 845-3887, geoffh@nipissingu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-Trial Performance in hypoxia conditions (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2024.