HypoxiaALTIPERFNCT02880150
Physiological Characteristics of High Altitude Climbers
A study testing Stress test in people with Hypoxia and Exercise, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Climbing at high altitude and tolerating hypoxic environment require specific physiological adaptations. Large intersubjects differences exist regarding the ability to adapt to high altitude and hypoxia. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Exercise, Sport Performance
- What is being tested?
- Stress test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40
- Member of the national high altitude climbing group
Who cannot join
- Any diseases incompatible with hypoxic exposure, exercise testing
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Climbing at high altitude and tolerating hypoxic environment require specific physiological adaptations. Large intersubjects differences exist regarding the ability to adapt to high altitude and hypoxia. The present study aims to characterise the physiological responses to hypoxia in a group of elite climbers by comparison to sea level athletes. We hypothesised that elite climbers would show better physiological responses to hypoxia and more preserved performances compared to sea level.
- Conditions
- Hypoxia, Exercise, Sport Performance
- Being tested
- Stress test
- Keywords
- elite climbers, near infrared spectroscopy
- Medical subject headings
- Hypoxia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress testOther
| Study group | Role | What they receive |
|---|---|---|
| Elite climbers | Other | Elite climbers selected in a national group for their previous performances at high altitude Receives: Other: Stress test |
| Sea level sportsmen | Other | Control group with similar anthropometric, age, gender and maximal normoxic oxygen consumption that the elite climber group Receives: Other: Stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance reduction in hypoxia versus normoxia
Difference in maximal cycling power output between the normoxic and the hypoxic exercise test
Measured: Day one on the evaluation day
Secondary outcomes (1)
Near infrared signals during exercise
Differences in cerebral and muscle TOI during exercise between the normoxia and the hypoxic exercise
Measured: Day one on the evaluation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880150
- Sponsor's protocol ID
- 2013-A00629-36
- Other IDs
- ALTIPERF
- Acronym
- ALTIPERF
- Status last verified
- Aug 2016
- First submitted
- 21 Oct 2013
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Verges S, Rupp T, Jubeau M, Wuyam B, Esteve F, Levy P, Perrey S, Millet GY. Cerebral perturbations during exercise in hypoxia. Am J Physiol Regul Integr Comp Physiol. 2012 Apr 15;302(8):R903-16. doi: 10.1152/ajpregu.00555.2011. Epub 2012 Feb 8.
PubMed 22319046
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Characteristics of High Altitude Climbers
- ClinicalTrials.gov ID
- NCT02880150
- Acronym / sponsor ID
- ALTIPERF / 2013-A00629-36
- Conditions
- Hypoxia, Exercise, Sport Performance
- Keywords
- elite climbers, near infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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.
Climbing at high altitude and tolerating hypoxic environment require specific physiological adaptations. Large intersubjects differences exist regarding the ability to adapt to high altitude and hypoxia. The present study aims to characterise the physiological responses to hypoxia in a group of elite climbers by comparison to sea level athletes. We hypothesised that elite climbers would show better physiological responses to hypoxia and more preserved performances compared to sea level.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elite climbers | Other | Other: Stress testElite climbers selected in a national group for their previous performances at high altitude |
| Sea level sportsmen | Other | Other: Stress testControl group with similar anthropometric, age, gender and maximal normoxic oxygen consumption that the elite climber group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18 and 40
- Member of the national high altitude climbing group
Key exclusion criteria (2 listed)
- Any diseases incompatible with hypoxic exposure, exercise testing
- Pregnancy
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 |
|---|---|---|
| Stress test | Other | Elite climbers, Sea level sportsmen |
Primary outcome
Performance reduction in hypoxia versus normoxia
Time frame: Day one on the evaluation day
Difference in maximal cycling power output between the normoxic and the hypoxic exercise test
1 secondary outcome
Near infrared signals during exercise
Time frame: Day one on the evaluation day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Background: PubMed 22319046Verges S, Rupp T, Jubeau M, Wuyam B, Esteve F, Levy P, Perrey S, Millet GY. Cerebral perturbations during exercise in hypoxia. Am J Physiol Regul Integr Comp Physiol. 2012 Apr 15;302(8):R903-16. doi: 10.1152/ajpregu.00555.2011. Epub 2012 Feb 8.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress test in people with Hypoxia and Exercise, run by University Hospital, Grenoble at 1 site in France.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 26 Aug 2016. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance reduction in hypoxia versus normoxia (time frame: Day one on the evaluation day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02880150, which also lists 1 linked publication.
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 26 Aug 2016.