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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05307276
Other study ID # 21-PP-10
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date July 1, 2023

Study information

Verified date September 2023
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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?


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date July 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Heliox
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.
Air
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).

Locations

Country Name City State
France CHU de Nice Nice Alpes-maritimes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline severity of EFL during ergocycle endurance exercise Force developed by the quadriceps muscle in response to percutaneous electrical stimulation of the femoral nerve At inclusion and 3 months
Secondary Muscle activation level estimated by measuring electromyographic (EMG) activity At inclusion and 3 months
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