- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05307276
Limitation of the Ventilatory Response to Exercise in the Master Athlete (LAHMESS)
September 5, 2023 updated by: Centre Hospitalier Universitaire de Nice
Limitation of the Ventilatory Response to Exercise in the Master Athlete: Influences on Locomotor Muscle Fatigue and on Endurance Performance
It is generally accepted that the ventilatory system is not a limiting factor in physical exercise in terms of performance or exercise tolerance in healthy subjects.
The ventilatory system would be oversized in relation to the stresses it has to cope with, even during maximum intensity exercise.
However, some highly trained endurance athletes may be exceptions to this rule.
A limitation of the expiratory flow is indeed sometimes found in these athletes, whose maximum values of ventilation can confront the mechanical limits of their ventilatory system.
This phenomenon could be accentuated in elderly athletes (known as "master athletes") under the effect of structural and functional pulmonary alterations that accompany aging.
Our hypothesis : What is the prevalence of exercise expiratory flow limitation in the master athlete and does it cause a decrease in physical performance via an acceleration of locomotor muscle fatigue?
Study Overview
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alpes-maritimes
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Nice, Alpes-maritimes, France, 06001
- CHU de Nice
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Non-smoker (active or passive) or ex-smoker of less than 5 pack-years and stopped for more than 10 years.
- No known significant chronic pathology.
- No symptoms suggesting a progressive pathology.
- No contraindication to physical exercise. Normal Pulmonary Functional Test (PFT).
- Participants affiliated to the social security system
Exclusion Criteria:
- Vulnerable persons as defined in Articles L. 1121-5 to L.1121-8 and L.1122-1-2 of the Public Health Code (e.g. persons deprived of liberty, minors, adults protected, etc.),
- Participants with a medical contraindication to sports practice,
- Cardiovascular, respiratory, neuromuscular and/or significant metabolic,
- Participants with declared pathology or medical treatment,
- Smoking or drug use,
- Significant chronic drug treatment,
- Lack of consent.
- Refusal to cooperate
- Recent rhino-bronchial infection (within last 4 weeks)
- Mental disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Healthy volunteers
Following the selection visit (#V0) to verify the inclusion and non-inclusion criteria, participants will make 2 visits (#V1 and #V2) including in particular a Respiratory Functional Exploration (EFR) and a triangular
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Participants will then complete 1 FAM (#V3) to Neuromuscular Function Assessment (PRE-POST), Pre- and Post- Exercise Ventilatory Function Assessment, and a Constant Load Ergocycle Test to Tolerance Limit (intensity fixed at 90% of the maximum aerobic power, PMA).
The following two experimental visits (#V4 and #V5) will replicate the tests described in #V3.
However, during the constant load exercise, participants will breathe either ambient air or heliox (a mixture in which the nitrogen in the air is replaced by the inert gas helium) in a random order.
During a final Experiential Visit (#V6), participants will replicate the "Medical Gas Administration" visit but the exercise will be interrupted when a similar amount of time/work as the ambient air condition is achieved.
Following the selection visit (#V0) to verify the inclusion and non-inclusion criteria, participants will make 2 visits (#V1 and #V2) including in particular a Respiratory Functional Exploration (EFR) and a triangular VO2 MAX estimation test in Ambient Air or Heliox conditions (depending on randomization).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline severity of EFL during ergocycle endurance exercise
Time Frame: At inclusion and 3 months
|
Force developed by the quadriceps muscle in response to percutaneous electrical stimulation of the femoral nerve
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At inclusion and 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle activation level
Time Frame: At inclusion and 3 months
|
estimated by measuring electromyographic (EMG) activity
|
At inclusion and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Leroy Sylvie, Pneumologie, CHU de Nice
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
April 1, 2023
Study Completion (Actual)
July 1, 2023
Study Registration Dates
First Submitted
March 8, 2022
First Submitted That Met QC Criteria
March 31, 2022
First Posted (Actual)
April 1, 2022
Study Record Updates
Last Update Posted (Actual)
September 8, 2023
Last Update Submitted That Met QC Criteria
September 5, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 21-PP-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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