VentilationWINDSURFNCT03440294
Wetsuit and Life Jacket Induced Effects on Spirometry and VO2 in Windsurfers
A study testing resting standard spirometry and maximum exercise testing in people with Ventilation and Exercise, run by University Hospital, Brest at 1 site in France.
Trial summary
The purpose of this study is to investigate the effect of wearing both neoprene suit and life jacket on respiratory capacities at rest and cardiopulmonary capacities during exercise in windsurfers. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilation, Exercise
- What is being tested?
- resting standard spirometry and maximum exercise testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2018to 18 Apr 2019
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 to 35
- Do not contraindicate any of the investigations in the study
- Being affiliated to a social security system
- free, informed and written consent
- Have already performed a cardiopulmonary exercise test without any electrocardiographic abnormality
- Subject practicing windsurfing (whatever the level of practice (leisure or competition))
Who cannot join
- Subjects < 18 years old
- Pregnant woman
- Inability to consent
- Taking any of the following: oral or inhaled Beta 2 short-acting or long-acting mimetics, oral or inhaled corticosteroids, oral anti-leukotrienes.
- Abnormalities in the resting ECG pattern
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Étude de l'Effet de la Combinaison néoprène et de l'équipement Individuel de Flottaison Sur la Fonction Respiratoire de Repos et Les capacités à l'Effort Chez Les véliplanchistes : étude WINDSURF
The purpose of this study is to investigate the effect of wearing both neoprene suit and life jacket on respiratory capacities at rest and cardiopulmonary capacities during exercise in windsurfers.
Read the detailed description
Windsurfers will perform resting spirometry and exercise test on cycle ergometer until exhaustion in two conditions: with or without equipment. The investigators will measure Forced Vital Capacity, FEV1 peak flow at rest and oxygen uptake, carbon dioxide consumption, ventilation at each step of the incremental exercise and at exhaustion.
- Conditions
- Ventilation, Exercise
- Being tested
- resting standard spirometry, maximum exercise testing
- Keywords
- windsurfer, wetsuit, spirometry, cardiopulmonary exercise testing, lung function, pulmonary function, oxygen uptake
- Medical subject headings
- Respiratory Aspiration, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resting standard spirometryDiagnostic test
The subject (seated, bust straightened) should perform, after a slow and maximum inspiration, a forced and complete exhalation followed by a new inspiration to the total lung capacity.
maximum exercise testingDiagnostic test
Incremental exercise on cycle ergometer with 100W start for men (80W for women) for 4 minutes as part of the warm-up. Then, step increment of a 50W power for men (40W for women) lasting 2 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| with neoprene suit and life jacket | Other | Realization of the following examinations WITH neoprene suit and life jacket :
* resting standard spirometry
* maximum exercise testing. No drug and no placebo will be used in this arm. Receives: Diagnostic Test: resting standard spirometry; Diagnostic Test: maximum exercise testing |
| without neoprene suit and life jacket | Other | Realization of the following examinations WITHOUT neoprene suit and life jacket :
* resting standard spirometry
* maximum exercise testing. No drug and no placebo will be used in this arm. Receives: Diagnostic Test: resting standard spirometry; Diagnostic Test: maximum exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC in L) at rest.
spirometry at rest
Measured: 1 day
Secondary outcomes (8)
Forced Expiratory Volume
FEV1 (in L)
Measured: 1 day
Peak Flow
PF (peak flow in L/s)
Measured: 1 day
mean flow rates
mean expiratory flow rates in L/ s at 75%, 50% and 25% of FVC (MEF 75, MEF 50, MEF 25).
Measured: 1 day
maximal ventilation
VE (ventilation in L/min)
Measured: 1 day
carbon dioxide production
VCO2 ( in L/min)
Measured: 1 day
oxygen consumption
VO2 ( in L/min)
Measured: 1 day
tidal volume
VT (in L)
Measured: 1 day
breathing frequency
RF (in breaths/min)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start22 Feb 2018
- Primary completion18 Apr 2019
- Study completion18 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VentilationStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Agnes Giroux-Metges, Pr, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440294
- Sponsor's protocol ID
- 29BRC17.0233
- Acronym
- WINDSURF
- Status last verified
- May 2019
- First submitted
- 31 Jan 2018
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Étude de l'Effet de la Combinaison néoprène et de l'équipement Individuel de Flottaison Sur la Fonction Respiratoire de Repos et Les capacités à l'Effort Chez Les véliplanchistes : étude WINDSURF
- ClinicalTrials.gov ID
- NCT03440294
- Acronym / sponsor ID
- WINDSURF / 29BRC17.0233
- Conditions
- Ventilation, Exercise
- Keywords
- windsurfer, wetsuit, spirometry, cardiopulmonary exercise testing, lung function, pulmonary function, oxygen uptake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 22 Feb 2018 (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.
The purpose of this study is to investigate the effect of wearing both neoprene suit and life jacket on respiratory capacities at rest and cardiopulmonary capacities during exercise in windsurfers.
Detailed description
Windsurfers will perform resting spirometry and exercise test on cycle ergometer until exhaustion in two conditions: with or without equipment. The investigators will measure Forced Vital Capacity, FEV1 peak flow at rest and oxygen uptake, carbon dioxide consumption, ventilation at each step of the incremental exercise and at exhaustion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with neoprene suit and life jacket | Other | Diagnostic Test: resting standard spirometry, Diagnostic Test: maximum exercise testingRealization of the following examinations WITH neoprene suit and life jacket : * resting standard spirometry * maximum exercise testing. No drug and no placebo will be used in this arm. |
| without neoprene suit and life jacket | Other | Diagnostic Test: resting standard spirometry, Diagnostic Test: maximum exercise testingRealization of the following examinations WITHOUT neoprene suit and life jacket : * resting standard spirometry * maximum exercise testing. No drug and no placebo will be used in this arm. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female aged 18 to 35
- Do not contraindicate any of the investigations in the study
- Being affiliated to a social security system
- free, informed and written consent
- Have already performed a cardiopulmonary exercise test without any electrocardiographic abnormality
Key exclusion criteria (5 listed)
- Subjects < 18 years old
- Pregnant woman
- Inability to consent
- Taking any of the following: oral or inhaled Beta 2 short-acting or long-acting mimetics, oral or inhaled corticosteroids, oral anti-leukotrienes.
- Abnormalities in the resting ECG pattern
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 |
|---|---|---|
| resting standard spirometryThe subject (seated, bust straightened) should perform, after a slow and maximum inspiration, a forced and complete exhalation followed by a new inspiration to the total lung capacity. | Diagnostic test | with neoprene suit and life jacket, without neoprene suit and life jacket |
| maximum exercise testingIncremental exercise on cycle ergometer with 100W start for men (80W for women) for 4 minutes as part of the warm-up. Then, step increment of a 50W power for men (40W for women) lasting 2 minutes each. | Diagnostic test | with neoprene suit and life jacket, without neoprene suit and life jacket |
Primary outcome
Forced Vital Capacity (FVC in L) at rest.
Time frame: 1 day
spirometry at rest
8 secondary outcomes
Forced Expiratory Volume
Time frame: 1 day
Peak Flow
Time frame: 1 day
mean flow rates
Time frame: 1 day
maximal ventilation
Time frame: 1 day
carbon dioxide production
Time frame: 1 day
oxygen consumption
Time frame: 1 day
tidal volume
Time frame: 1 day
breathing frequency
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
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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.
Marie Agnes Giroux-Metges, Pr principal investigator
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resting standard spirometry and maximum exercise testing in people with Ventilation and Exercise, run by University Hospital, Brest 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 7 May 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Forced Vital Capacity (FVC in L) at rest. (time frame: 1 day). 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 7 May 2019.