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NCT03743610 Clinical Trial

Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance

Altitude Hypoxia Clinical Trial

Official title:
Investigation of Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03743610
Other study ID # 18-000484
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date October 25, 2023

Study information
Verified date February 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. This may furthermore be related to acute altitude exposure for recreational exercise use as well.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date October 25, 2023
Est. primary completion date October 19, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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 simulated altitude
Participants will exercise at sea level at similar percentage of intensities to the simulated altitude group.

Locations
Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in hemoglobin Baseline, 2-week, 4-week, 6-week, and 8-week
Primary Change in hematocrit Baseline, 2-week, 4-week, 6-week, and 8-week
Primary Change in erythropoietin Baseline, 2-week, 4-week, 6-week, and 8-week
Secondary Change in peak VO2 Change from maximal exercise test performed at sea level Baseline and 6- and 8-week
Secondary Change in cycling performance at altitude change in aerobic/anaerobic cycling performance at altitude Baseline and 6- and 8-week
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