Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance

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.

Study Overview

• Status: Completed
• Conditions: Altitude Hypoxia
• Intervention / Treatment: Other: Simulated altitude; Other: Placebo simulated altitude

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in hemoglobin	Baseline, 2-week, 4-week, 6-week, and 8-week
Change in hematocrit	Baseline, 2-week, 4-week, 6-week, and 8-week
Change in erythropoietin	Baseline, 2-week, 4-week, 6-week, and 8-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peak VO2	Change from maximal exercise test performed at sea level	Baseline and 6- and 8-week
Change in cycling performance at altitude	change in aerobic/anaerobic cycling performance at altitude	Baseline and 6- and 8-week

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Courtney M Wheatley, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): October 19, 2023
• Study Completion (Actual): October 25, 2023

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Altitude Sickness; Hypoxia
• Other Study ID Numbers: 18-000484 (Other Identifier: UCLA / Jonsson Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No