Altitude HypoxiaNCT03743610
Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance
A study testing Simulated altitude in people with Altitude Hypoxia, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators expect to find that different intensity and altitude exposure levels will show what kind of intermittent exposure protocol is more beneficial to athletes and healthy individuals that experience acute exposure to altitude during exercise. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Altitude Hypoxia
- What is being tested?
- Simulated altitude
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 25 Oct 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-70 years of age,
- history of good health,
- generally active to competitive athletes.
Who cannot join
- History of cardiac or pulmonary disease,
- not currently active,
- unable to exercise or meet study requirements (e.g., number of sessions),
- live at altitude (>2,100m or 7,000ft).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance
The investigators expect to find that different intensity and altitude exposure levels will show what kind of intermittent exposure protocol is more beneficial to athletes and healthy individuals that experience acute exposure to altitude during exercise. This may furthermore be related to acute altitude exposure for recreational exercise use as well.
- Conditions
- Altitude Hypoxia
- Being tested
- Simulated altitude, Placebo simulated altitude
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated altitudeOther
Participants will exercise in simulated altitude will range between 2100 feet and 16400 feet and will increase according to arm guidelines
Placebo simulated altitudeOther
Participants will exercise at sea level at similar percentage of intensities to the simulated altitude group.
| Study group | Role | What they receive |
|---|---|---|
| Effect of heart rate training in simulated altitude | Experimental | Participants will exercise in simulated altitude start at a minimum of 2,000ft and will increase to no greater than 16,400ft with each visit. The increase will be in accordance to maintaining >65% max heart rate during room air based maximal peak work. Receives: Other: Simulated altitude |
| Effect of saturation of oxygen training in simulated altitude | Experimental | Participants will exercise in simulated altitude start at a minimum of 2,000ft and will increase to no greater than 16,400ft with each visit. The increase will be in accordance to maintaining 40-60% of max work rate during room air work rate and based upon saturation of oxygen of between 70-80%. Receives: Other: Simulated altitude |
| Effect of optimized training in simulated altitude | Active comparator | Participants will perform the more beneficial intervention (heart rate or saturation of oxygen training) to evaluate whether it improves elite athlete's training status at altitude. Receives: Other: Simulated altitude |
| Effect of placebo training in non-simulated altitude | Placebo comparator | Participants will perform placebo beneficial intervention (heart rate or saturation of oxygen training) to evaluate whether the optimized protocol truely improves elite athlete's training status at altitude. Receives: Other: Placebo simulated altitude |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin
Measured: Baseline, 2-week, 4-week, 6-week, and 8-week
Change in hematocrit
Measured: Baseline, 2-week, 4-week, 6-week, and 8-week
Change in erythropoietin
Measured: Baseline, 2-week, 4-week, 6-week, and 8-week
Secondary outcomes (2)
Change in peak VO2
Change from maximal exercise test performed at sea level
Measured: Baseline and 6- and 8-week
Change in cycling performance at altitude
change in aerobic/anaerobic cycling performance at altitude
Measured: Baseline and 6- and 8-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Jan 2019
- Primary completion19 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Altitude HypoxiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney M. Wheatley, Mayo Clinic
- Investigators
- Courtney M Wheatley, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743610
- Sponsor's protocol ID
- 18-000484
- Status last verified
- Feb 2024
- First submitted
- 12 Nov 2018
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance
- ClinicalTrials.gov ID
- NCT03743610
- Acronym / sponsor ID
- 18-000484
- Conditions
- Altitude Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 16 Nov 2018 (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 investigators expect to find that different intensity and altitude exposure levels will show what kind of intermittent exposure protocol is more beneficial to athletes and healthy individuals that experience acute exposure to altitude during exercise. This may furthermore be related to acute altitude exposure for recreational exercise use as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Effect of heart rate training in simulated altitude | Experimental | Other: Simulated altitudeParticipants will exercise in simulated altitude start at a minimum of 2,000ft and will increase to no greater than 16,400ft with each visit. The increase will be in accordance to maintaining >65% max heart rate during room air based maximal peak work. |
| Effect of saturation of oxygen training in simulated altitude | Experimental | Other: Simulated altitudeParticipants will exercise in simulated altitude start at a minimum of 2,000ft and will increase to no greater than 16,400ft with each visit. The increase will be in accordance to maintaining 40-60% of max work rate during room air work rate and based upon saturation of oxygen of between 70-80%. |
| Effect of optimized training in simulated altitude | Active comparator | Other: Simulated altitudeParticipants will perform the more beneficial intervention (heart rate or saturation of oxygen training) to evaluate whether it improves elite athlete's training status at altitude. |
| Effect of placebo training in non-simulated altitude | Placebo comparator | Other: Placebo simulated altitudeParticipants will perform placebo beneficial intervention (heart rate or saturation of oxygen training) to evaluate whether the optimized protocol truely improves elite athlete's training status at altitude. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-70 years of age,
- history of good health,
- generally active to competitive athletes.
Key exclusion criteria (4 listed)
- History of cardiac or pulmonary disease,
- not currently active,
- unable to exercise or meet study requirements (e.g., number of sessions),
- live at altitude (>2,100m or 7,000ft).
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 |
|---|---|---|
| Simulated altitudeParticipants will exercise in simulated altitude will range between 2100 feet and 16400 feet and will increase according to arm guidelines | Other | Effect of heart rate training in simulated altitude, Effect of optimized training in simulated altitude, Effect of saturation of oxygen training in simulated altitude |
| Placebo simulated altitudeParticipants will exercise at sea level at similar percentage of intensities to the simulated altitude group. | Other | Effect of placebo training in non-simulated altitude |
Primary outcome
Change in hemoglobin
Time frame: Baseline, 2-week, 4-week, 6-week, and 8-week
Change in hematocrit
Time frame: Baseline, 2-week, 4-week, 6-week, and 8-week
Change in erythropoietin
Time frame: Baseline, 2-week, 4-week, 6-week, and 8-week
2 secondary outcomes
Change in peak VO2
Time frame: Baseline and 6- and 8-week
Change in cycling performance at altitude
Time frame: Baseline and 6- and 8-week
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 20 Feb 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Courtney M Wheatley principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated altitude in people with Altitude Hypoxia, run by Mayo Clinic at 1 site in United States.
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 3 inclusion and 4 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 20 Feb 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 United States. 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. Some participants in this study may receive a placebo. 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?
Change in hemoglobin (time frame: Baseline, 2-week, 4-week, 6-week, and 8-week). The study lists 3 primary outcomes in all. 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 20 Feb 2024.