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

Acute Mountain Sickness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05798416
• Other study ID #: 2020 No.37
• Status: Completed
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: April 29, 2023

Study information

• Verified date: May 2023
• Source: State Key Laboratory of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 29, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness
• High Altitude
• Inhalation; Gas
• Respiratory Aspiration

Intervention

Drug:
• Exercise under inhalation CO2
Participants perform shuttle walk test at high altitude while using the novel portable device for inhalation of CO2

Other:
• Exercise under inhalation ambient air
Participants perform shuttle walk test at high altitude while inhaling ambient air

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
State Key Laboratory of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the distance in walking test	Changes in walking distance under inhalation of CO2 and ambient air	48 hours