Effect of Inhalation of Low Dose CO2 on Exercise Performance at High Altitude

Effect of Supplement of CO2 Using Novel Portable Device on Exercise Performance at High Altitude

High altitude (>2400 m) is associated with decreased atmosphere pressure leading to hypoxia which in turn impairs exercise capacity and causes acute mountain sickness (AMS). It is noted that adding CO2 might be beneficial to improve hypoxia and exercise performance at high altitude. However, no device is currently available that can supply a constant low dose of CO2 during free movement at high altitude. We have recently invented a portable device which is small and light enough for supplement of low dose CO2 during field exercise at high altitude.

Study Overview

• Status: Completed
• Conditions: Acute Mountain Sickness; High Altitude; Inhalation; Gas
• Intervention / Treatment: Drug: Exercise under inhalation CO2; Other: Exercise under inhalation ambient air

Detailed Description

Objective: To determine whether the supplement of low-dose CO2 by the novel device could improve exercise performance at high altitude.

Methods: The lowlanders (<500m) who have no history of travelling to high altitude (>1000m) a year before the study will be recruited. And the subjects who are high-altitude residents and have not left high altitude over the last twelve months will also be recruited for the study. Subjects will be randomly and blindly given either CO2 mixed with air or air alone during endurance shuttle walking test (ESWT). Blood gases will be measured before and after inhalation of CO2. ESWT time, ventilation per minute (VE), blood oxygen saturation (SPO2), and end-tidal CO2 concentration (ETCO2) will be measured during exercise and will be compared during inhalation of CO2 and during inhalation of ambient air.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Healthy lowlanders (<500m) who have no history to travel to high altitude (>1000m) a year before the study.
2. Healthy high altitude (4500m) residents who have not left the inhabited area over the last twelve months before the study.

Exclusion Criteria:

1. Subjects with cardiovascular diseases, respiratory diseases and neuromuscular diseases which could affect exercise.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercise under inhalation of CO2; Subjects will perform shuttle walk test under inhalation of low concentration of CO2 supplied by a novel device at high altitude.	Drug: Exercise under inhalation CO2; Participants perform shuttle walk test at high altitude while using the novel portable device for inhalation of CO2; Other Names: inhalation of low dose CO2
Placebo Comparator: Exercise under inhalation of ambient air; Subjects will perform shuttle walk test under inhalation of ambient air at high altitude.	Other: Exercise under inhalation ambient air; Participants perform shuttle walk test at high altitude while inhaling ambient air

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the distance in walking test	Changes in walking distance under inhalation of CO2 and ambient air	48 hours

Collaborators and Investigators

• Sponsor: State Key Laboratory of Respiratory Disease
• Investigators: Principal Investigator: Yuanming Luo, PhD, The Affiliated Hospital og Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): April 29, 2023

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: High altitude; Exercise performance; CO2 inhalation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Altitude Sickness
• Other Study ID Numbers: 2020 No.37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be shared after the paper of this study publishing.
• IPD Sharing Time Frame: The data will be shared after the paper of this study publishing.
• IPD Sharing Access Criteria: After the paper of this study publishing
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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