Oxygen Transport in Normobaric vs. Hypobaric Hypoxia

NCT03335917 | Completed

• 1 other identifier: 0209-17-FB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

1\) Oxygen Transport in Normobaric versus Hypobaric Hypoxia. 2) The purpose of this study is to examine acute responses in arterial and muscle tissue oxygenation during incremental exercise in normobaric versus hypobaric hypoxia. 3) The participants in this study will consist of 12 recreationally active males and females between the ages of 19 and 45.Recreationally active is defined as participating in moderate to vigorous physical activity for 30 minutes at least 3 days per week.4) Subjects will complete an incremental cycle test to volitional fatigue in three conditions in a randomized counter-balanced order, normobaric normoxia (20.9% O2, 730 mmHg), normobaric hypoxia (14.3% O2, 730 mmHg) and hypobaric hypoxia (20.9% O2, 530mmHg). Two of the three trials will be conducted in an environmental chamber to simulate normobaric normoxia at 350 m (elevation of Omaha, NE) and normobaric hypoxia at 3094 m (elevation of Leadville, CO). The hypobaric hypoxia trial will be conducted in Leadville, Colorado at 3094 m. Trials will be separated by at least two days. Rating of perceived exertion, heart rate, blood oxygenation, respiration rate, muscle tissue oxygenation, and whole body gases will be analyzed during the trials. 5) There is no follow-up as a part of this study.

Conditions

Hypoxia, Altitude; Exercise

Outcome Measures

Primary Outcomes (1)

• Change in Muscle Oxygenation

  % O2 sat in muscle using NIRS

  change from baseline at 0 minutes after exercise

Study Arms (3)

Normobaric Normoxia

PLACEBO COMPARATOR

This will serve as the exercise only control trial

Other: Exercise

Normobaric Hypoxia

EXPERIMENTAL

This arm will provide hypoxia by reducing the amount of oxygen concentration without changing the barometric pressure

Other: Hypoxia; Other: Exercise

Hypobaric Hypoxia

EXPERIMENTAL

This arm will provide hypoxia by reducing the barometric pressure without changing the oxygen concentration (terrestrial altitude exposure)

Other: Hypoxia; Other: Exercise

Interventions

Hypoxia OTHER

Participants will be exposed to hypoxia by reducing barometric pressure or by reducing oxygen concentration

Hypobaric Hypoxia; Normobaric Hypoxia

Exercise OTHER

Graded cycling exercise to volitional fatigue

Hypobaric Hypoxia; Normobaric Hypoxia; Normobaric Normoxia

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be recreationally active Recreationally active is defined as participating in moderate to vigorous physical activity for 30 minutes at least 3 days per week.-females or males between the ages of 19 and 45.
• All participants must be considered "low risk" according to ACSM risk stratification.
• participants must be free from any ECG or blood pressure abnormalities as assessed during maximal testing.

You may not qualify if:

• All subjects who are considered higher than "low risk" according to the ACSM risk stratification guidelines will be excluded from this study.
• Any participant under 19 years of age or over the age 45 and who list any health related condition that may interfere or become exacerbated by participating in this research would be excluded from this study.
• Participants taking any prescription drugs, other than female contraceptives, will be excluded from participation.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska at Omaha

Omaha, Nebraska, 68182, United States

Location

MeSH Terms

Conditions

Altitude Sickness; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dustin R Slivka, PhD

  University of Montana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized,Counter Balanced, Repeated Measures, Crossover

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: November 8, 2017
• Study Start: August 15, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)