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

Primary Purpose

High Altitude, Inhalation; Gas, Acute Mountain Sickness

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Exercise under inhalation CO2
Exercise under inhalation ambient air
Sponsored by
State Key Laboratory of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Altitude focused on measuring High altitude, Exercise performance, CO2 inhalation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy lowlanders (<500m) who have no history to travel to high altitude (>1000m) a year before the study. 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.

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Exercise under inhalation of CO2

Exercise under inhalation of ambient air

Arm Description

Subjects will perform shuttle walk test under inhalation of low concentration of CO2 supplied by a novel device at high altitude.

Subjects will perform shuttle walk test under inhalation of ambient air at high altitude.

Outcomes

Primary Outcome Measures

Change of the distance in walking test
Changes in walking distance under inhalation of CO2 and ambient air

Secondary Outcome Measures

Full Information

First Posted
March 10, 2023
Last Updated
May 17, 2023
Sponsor
State Key Laboratory of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT05798416
Brief Title
Effect of Inhalation of Low Dose CO2 on Exercise Performance at High Altitude
Official Title
Effect of Supplement of CO2 Using Novel Portable Device on Exercise Performance at High Altitude
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
April 15, 2023 (Actual)
Study Completion Date
April 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State Key Laboratory of Respiratory Disease

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Altitude, Inhalation; Gas, Acute Mountain Sickness
Keywords
High altitude, Exercise performance, CO2 inhalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise under inhalation of CO2
Arm Type
Active Comparator
Arm Description
Subjects will perform shuttle walk test under inhalation of low concentration of CO2 supplied by a novel device at high altitude.
Arm Title
Exercise under inhalation of ambient air
Arm Type
Placebo Comparator
Arm Description
Subjects will perform shuttle walk test under inhalation of ambient air at high altitude.
Intervention Type
Drug
Intervention Name(s)
Exercise under inhalation CO2
Other Intervention Name(s)
inhalation of low dose CO2
Intervention Description
Participants perform shuttle walk test at high altitude while using the novel portable device for inhalation of CO2
Intervention Type
Other
Intervention Name(s)
Exercise under inhalation ambient air
Intervention Description
Participants perform shuttle walk test at high altitude while inhaling ambient air
Primary Outcome Measure Information:
Title
Change of the distance in walking test
Description
Changes in walking distance under inhalation of CO2 and ambient air
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy lowlanders (<500m) who have no history to travel to high altitude (>1000m) a year before the study. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanming Luo, PhD
Organizational Affiliation
The Affiliated Hospital og Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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