The Influence of Cerebral Blood Flow and PETCO2 on Neuromuscular Function During Passive Heat Stress

NCT ID: NCT01848665

Last Updated: 2018-01-29

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Increased core temperature (hyperthermia) has been associated with impaired neuromuscular performance; however, the mechanisms associated with these performance decrements and their potential synergies remain unclear. While the majority of research suggests that the observed fatigue is related to the central nervous system, the influence of changes in cerebral blood flow (CBF) and associated changes in cerebral alkalosis (estimated by end-tidal partial pressure of carbon dioxide; PETCO2) remains unexamined. In response to hyperthermia, humans hyperventilate as means of heat dissipation, resulting in a hypocapnia (reduced PETCO2) mediated decrease in CBF and consequently, cerebral alkalosis (increased cerebral pH). Previous research suggests that hyperventilation induces changes in neural excitability and synaptic transmission; however, it remains unclear if these changes are related to hypocapnia mediated decrease in CBF or decreased PETCO2 or both.

The purpose of the proposed research program is to examine the influence of changes in CBF and cerebral alkalosis on neuromuscular function during passive heat stress. The research project will consist of 3 separate experimental trials: (a) poikilocapnic hyperthermia (increased core temperature; decrease CBF; decrease PETCO2), (b) isocapnic hyperthermia (increased core temperature; no change CBF; no change PETCO2) and (c) isocapnic hyperthermia + indomethacin (increased core temperature; decrease CBF; no change PETCO2). During each manipulation, neuromuscular function will be evaluated and compared to baseline (normothermic) conditions using a repeated measures design.

It is hypothesized that changes in PETCO2 and therefore, changes in cerebral alkalosis will contribute to neuromuscular fatigue independent of changes in CBF or increases in core temperature.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Males Neuromuscular Function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Drug

Indomethacin, 1.2 mg kg 1 dose

Group Type EXPERIMENTAL

Indomethacin

Intervention Type DRUG

Placebo

generic flour placebo capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Indomethacin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 to 45 yrs old; healthy males

Exclusion Criteria

* diagnosed medical condition; NSAID allergy; smoker; high altitude exposure; implants
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brock University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stephen Cheung

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brock University

St. Catharines, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EEL 073.3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Microvascular Blood Flow During Passive Heating
NCT06565221 NOT_YET_RECRUITING NA
Heat, Microvascular Function and Aging
NCT06633198 RECRUITING EARLY_PHASE1