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Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743610
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Courtney M. Wheatley, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Altitude Hypoxia Other: Simulated altitude Other: Placebo simulated altitude Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Investigation of Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Effect of heart rate training in simulated altitude
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.
Other: Simulated altitude
Participants will exercise in simulated altitude will range between 2100 feet and 16400 feet and will increase according to arm guidelines

Experimental: Effect of saturation of oxygen training in simulated altitude
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%.
Other: Simulated altitude
Participants will exercise in simulated altitude will range between 2100 feet and 16400 feet and will increase according to arm guidelines

Active Comparator: Effect of optimized training in simulated altitude
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.
Other: Simulated altitude
Participants will exercise in simulated altitude will range between 2100 feet and 16400 feet and will increase according to arm guidelines

Placebo Comparator: Effect of placebo training in non-simulated 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.
Other: Placebo simulated altitude
Participants will exercise at sea level at similar percentage of intensities to the simulated altitude group.




Primary Outcome Measures :
  1. Change in hemoglobin [ Time Frame: Baseline, 2-week, 4-week, 6-week, and 8-week ]
  2. Change in hematocrit [ Time Frame: Baseline, 2-week, 4-week, 6-week, and 8-week ]
  3. Change in erythropoietin [ Time Frame: Baseline, 2-week, 4-week, 6-week, and 8-week ]

Secondary Outcome Measures :
  1. Change in peak VO2 [ Time Frame: Baseline and 6- and 8-week ]
    Change from maximal exercise test performed at sea level

  2. Change in cycling performance at altitude [ Time Frame: Baseline and 6- and 8-week ]
    change in aerobic/anaerobic cycling performance at altitude



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743610


Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Courtney Wheatley-Guy, PhD    480-301-6616    Wheatley.Courtney@mayo.edu   
Principal Investigator: Courtney M Wheatley         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Courtney M Wheatley Mayo Clinic
Additional Information:
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Responsible Party: Courtney M. Wheatley, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03743610    
Other Study ID Numbers: 18-000484
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Altitude Sickness
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases