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

NCT ID: NCT05798416

Last Updated: 2023-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-04-29

Brief Summary

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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

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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.

Conditions

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High Altitude Inhalation; Gas Acute Mountain Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Exercise under inhalation CO2

Intervention Type DRUG

Participants perform shuttle walk test at high altitude while using the novel portable device for inhalation of CO2

Exercise under inhalation of ambient air

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

Group Type PLACEBO_COMPARATOR

Exercise under inhalation ambient air

Intervention Type OTHER

Participants perform shuttle walk test at high altitude while inhaling ambient air

Interventions

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Exercise under inhalation CO2

Participants perform shuttle walk test at high altitude while using the novel portable device for inhalation of CO2

Intervention Type DRUG

Exercise under inhalation ambient air

Participants perform shuttle walk test at high altitude while inhaling ambient air

Intervention Type OTHER

Other Intervention Names

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inhalation of low dose CO2

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State Key Laboratory of Respiratory Disease

OTHER

Sponsor Role lead

Responsible Party

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Yuan-Ming Luo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuanming Luo, PhD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital og Guangzhou Medical University

Locations

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The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2020 No.37

Identifier Type: -

Identifier Source: org_study_id

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