CClinicalTrials.gg
Sign In
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

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.

02

Conditions studied

  • Ventilation
  • Exercise

Keywords

  • windsurfer
  • wetsuit
  • spirometry
  • cardiopulmonary exercise testing
  • lung function
  • pulmonary function
  • oxygen uptake
03

Who can participate

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

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 corticosteroids, oral anti-leukotrienes.
  • Abnormalities in the resting ECG pattern
04

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.

05

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

06

Study locations

1 site
  • University hospital
    Brest, 29200, France
07

Registry details

Key details

Study ID
NCT03440294
Lead sponsor
University Hospital, Brest
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University Hospital, Brest

Start the discussion