Healthy VolunteersLAHMESSNCT05307276
Limitation of the Ventilatory Response to Exercise in the Master Athlete
A study testing Heliox and Air in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Heliox and Air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- Lack of consent.
- Refusal to cooperate
- Recent rhino-bronchial infection (within last 4 weeks)
- Mental disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
- Conditions
- Healthy Volunteers
- Being tested
- Heliox, Air
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HelioxOther
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.
AirOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Heliox; Other: Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At inclusion and 3 months
Secondary outcomes (1)
Muscle activation level
estimated by measuring electromyographic (EMG) activity
Measured: At inclusion and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2023
- Study completion1 Jul 2023
Why it stopped: Organisation problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leroy Sylvie, Principal investigator, Pneumologie, CHU de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307276
- Sponsor's protocol ID
- 21-PP-10
- Acronym
- LAHMESS
- Status last verified
- Sep 2023
- First submitted
- 8 Mar 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limitation of the Ventilatory Response to Exercise in the Master Athlete: Influences on Locomotor Muscle Fatigue and on Endurance Performance
- ClinicalTrials.gov ID
- NCT05307276
- Acronym / sponsor ID
- LAHMESS / 21-PP-10
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Organisation problem
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Other: Heliox, Other: AirFollowing 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HelioxParticipants 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. | Other | Healthy volunteers |
| AirFollowing 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). | Other | Healthy volunteers |
Primary outcome
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
1 secondary outcome
Muscle activation level
Time frame: At inclusion and 3 months
Results and safety
The study was stopped early (reason given: Organisation problem). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leroy Sylvie principal investigator
Pneumologie, CHU de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heliox and Air in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Organisation problem). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline severity of EFL during ergocycle endurance exercise (time frame: At inclusion and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.