NCT03743610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

4.8 years

First QC Date

November 12, 2018

Last Update Submit

February 16, 2024

Conditions

Altitude Hypoxia

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Change in peak VO2

    Baseline and 6- and 8-week

  • Change in cycling performance at altitude

    Baseline and 6- and 8-week

Study Arms (4)

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.

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%.

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.

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.

Other: Placebo simulated altitude

Interventions

Simulated altitudeOTHER

Participants will exercise in simulated altitude will range between 2100 feet and 16400 feet and will increase according to arm guidelines

Effect of heart rate training in simulated altitudeEffect of optimized training in simulated altitudeEffect of saturation of oxygen training in simulated altitude
Placebo simulated altitudeOTHER

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

Effect of placebo training in non-simulated altitude

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age,
  • history of good health,
  • generally active to competitive athletes.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Courtney M Wheatley

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2018

First Posted

November 16, 2018

Study Start

January 1, 2019

Primary Completion

October 19, 2023

Study Completion

October 25, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)