Limitation of the Ventilatory Response to Exercise in the Master Athlete

NCT05307276 | Terminated

• 1 other identifier: 21-PP-10
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Muscle activation level

  At inclusion and 3 months

Study Arms (1)

Healthy volunteers

OTHER

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

Other: Heliox; Other: Air

Interventions

Heliox OTHER

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.

Healthy volunteers

Air OTHER

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).

Healthy volunteers

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes-maritimes, 06001, France

Location

MeSH Terms

Interventions

heliox; Air

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Leroy Sylvie

  Pneumologie, CHU de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 1, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: July 1, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)