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

NCT05798416 | Completed

• 1 other identifier: 2020 No.37
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

High Altitude; Inhalation; Gas; Acute Mountain Sickness

Keywords

High altitude; Exercise performance; CO2 inhalation

Outcome Measures

Primary Outcomes (1)

• Change of the distance in walking test

  Changes in walking distance under inhalation of CO2 and ambient air

  48 hours

Study Arms (2)

Exercise under inhalation of CO2

ACTIVE COMPARATOR

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

Exercise under inhalation of ambient air

PLACEBO COMPARATOR

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

Other: Exercise under inhalation ambient air

Interventions

Exercise under inhalation CO2 DRUG

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

Also known as: inhalation of low dose CO2

Exercise under inhalation of CO2

Exercise under inhalation ambient air OTHER

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

Exercise under inhalation of ambient air

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• State Key Laboratory of Respiratory Disease: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Altitude Sickness; Respiratory Aspiration; Mucopolysaccharidosis IV

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yuanming Luo, PhD

  The Affiliated Hospital og Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 4, 2023
• Study Start: February 15, 2023
• Primary Completion: April 15, 2023
• Study Completion: April 29, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be shared after the paper of this study publishing.
• Access Criteria: After the paper of this study publishing

Locations

CN (1)