ClinicalTrials.gg
CompletedNCT03440294WINDSURFUpdated May 7, 2019

Wetsuit and Life Jacket Induced Effects on Spirometry and VO2 in Windsurfers

An interventional study of resting standard spirometry and maximum exercise testing in Ventilation and Exercise, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-07.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 367 studies in Motor Activity with a site in France — 78 open to participants now, 90 under way, none of them phase 3. Motor Activity · France.

Enrollment
192nd of 269
34 · median 62
Started
2018
with 21 others
No phase
254 of 367
52 open now
Registered
126th of 367
by date
Lead sponsor
9 of 367
University Hospital, Brest

Among the 367 studies in Motor Activity with a site in France, this one is the 192nd largest by enrollment of the 269 interventional ones that give a count, is one of 22 that started in 2018, is one of 254 with no phase, and was the 126th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

78 of the 367 studies in Motor Activity with a site in France are open now. Recruiting first, the newest first:

73 more — sign in →

All 78 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years to 35 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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 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.

03

Conditions studied

  • Ventilation
  • Exercise

Browse trials for

Keywords

  • windsurfer
  • wetsuit
  • spirometry
  • cardiopulmonary exercise testing
  • lung function
  • pulmonary function
  • oxygen uptake
04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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))

Exclusion criteria

Exclusion Criteria:

  • 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 , oral anti-leukotrienes.
  • Abnormalities in the resting pattern
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Other
    with neoprene suit and life jacket

    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.

    Diagnostic Test: resting standard spirometry · Diagnostic Test: maximum exercise testing

  • Other
    without neoprene suit and life jacket

    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.

    Diagnostic Test: resting standard spirometry · Diagnostic Test: maximum exercise testing

Interventions

  • Diagnostic testresting standard spirometry

    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.

  • Diagnostic testmaximum exercise testing

    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.

06

What researchers measure

Primary outcomes

  1. Forced Vital Capacity (FVC in L) at rest.

    spirometry at rest

    Time frame: 1 day

Secondary outcomes

  1. Forced Expiratory Volume

    FEV1 (in L)

    Time frame: 1 day

  2. Peak Flow

    PF (peak flow in L/s)

    Time frame: 1 day

  3. mean flow rates

    mean expiratory flow rates in L/ s at 75%, 50% and 25% of FVC (MEF 75, MEF 50, MEF 25).

    Time frame: 1 day

  4. maximal ventilation

    VE (ventilation in L/min)

    Time frame: 1 day

  5. carbon dioxide production

    VCO2 ( in L/min)

    Time frame: 1 day

  6. oxygen consumption

    VO2 ( in L/min)

    Time frame: 1 day

  7. tidal volume

    VT (in L)

    Time frame: 1 day

  8. breathing frequency

    RF (in breaths/min)

    Time frame: 1 day

07

Study locations

1 site
  • University hospital
    Brest, 29200, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Apr 2019, 13 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 13 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2018
First posted
Feb 22, 2018
StartActual
Feb 22, 2018
Primary completionActual
Apr 18, 2019
CompletionActual
Apr 18, 2019
Last update
May 7, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03440294
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Feb 22, 2018
Primary completion
Apr 18, 2019
Completion
Apr 18, 2019
Last update
May 7, 2019

Study contacts

Marie Agnes Giroux-Metges, Pr
principal investigator · CHRU de Brest

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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