NCT03440294

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 22, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

January 31, 2018

Last Update Submit

May 3, 2019

Conditions

VentilationExercise

Keywords

windsurferwetsuitspirometrycardiopulmonary exercise testinglung functionpulmonary functionoxygen uptake

Outcome Measures

Primary Outcomes (1)

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

    spirometry at rest

    1 day

Secondary Outcomes (8)

  • Forced Expiratory Volume

    1 day

  • Peak Flow

    1 day

  • mean flow rates

    1 day

  • maximal ventilation

    1 day

  • carbon dioxide production

    1 day

  • +3 more secondary outcomes

Study Arms (2)

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.

Diagnostic Test: resting standard spirometryDiagnostic 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.

Diagnostic Test: resting standard spirometryDiagnostic Test: maximum exercise testing

Interventions

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.

with neoprene suit and life jacketwithout neoprene suit and life jacket
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.

with neoprene suit and life jacketwithout neoprene suit and life jacket

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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))

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Brest, 29200, France

Location

MeSH Terms

Conditions

Respiratory AspirationMotor Activity

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Marie Agnes Giroux-Metges, Pr

    CHRU de Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 22, 2018

Study Start

February 22, 2018

Primary Completion

April 18, 2019

Study Completion

April 18, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

FR(1)