Back to resultsPhysiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance
Primary Purpose
Altitude Hypoxia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simulated altitude
Placebo simulated altitude
Sponsored by
About this trial
This is an interventional prevention trial for Altitude Hypoxia
Eligibility Criteria
Inclusion criteria:
- 18-70 years of age,
- history of good health,
- generally active to competitive athletes.
Exclusion criteria:
- 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).
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Effect of heart rate training in simulated altitude
Effect of saturation of oxygen training in simulated altitude
Effect of optimized training in simulated altitude
Effect of placebo training in non-simulated altitude
Arm Description
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.
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%.
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.
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.
Outcomes
Primary Outcome Measures
Change in hemoglobin
Change in hematocrit
Change in erythropoietin
Secondary Outcome Measures
Change in peak VO2
Change from maximal exercise test performed at sea level
Change in cycling performance at altitude
change in aerobic/anaerobic cycling performance at altitude
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03743610
Brief Title
Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance
Official Title
Investigation of Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. This may furthermore be related to acute altitude exposure for recreational exercise use as well.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Altitude Hypoxia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Effect of heart rate training in simulated altitude
Arm Type
Experimental
Arm Description
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.
Arm Title
Effect of saturation of oxygen training in simulated altitude
Arm Type
Experimental
Arm Description
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%.
Arm Title
Effect of optimized training in simulated altitude
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Effect of placebo training in non-simulated altitude
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Simulated altitude
Intervention Description
Participants will exercise in simulated altitude will range between 2100 feet and 16400 feet and will increase according to arm guidelines
Intervention Type
Other
Intervention Name(s)
Placebo simulated altitude
Intervention Description
Participants will exercise at sea level at similar percentage of intensities to the simulated altitude group.
Primary Outcome Measure Information:
Title
Change in hemoglobin
Time Frame
Baseline, 2-week, 4-week, 6-week, and 8-week
Title
Change in hematocrit
Time Frame
Baseline, 2-week, 4-week, 6-week, and 8-week
Title
Change in erythropoietin
Time Frame
Baseline, 2-week, 4-week, 6-week, and 8-week
Secondary Outcome Measure Information:
Title
Change in peak VO2
Description
Change from maximal exercise test performed at sea level
Time Frame
Baseline and 6- and 8-week
Title
Change in cycling performance at altitude
Description
change in aerobic/anaerobic cycling performance at altitude
Time Frame
Baseline and 6- and 8-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
18-70 years of age,
history of good health,
generally active to competitive athletes.
Exclusion criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney M Wheatley
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance
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