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

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT03440294

Collaborator

(none)

Enrollment

Location

Arms

13.8

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilation Exercise	Diagnostic Test: resting standard spirometry Diagnostic Test: maximum exercise testing	N/A

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

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Feb 22, 2018

Actual Primary Completion Date :

Apr 18, 2019

Actual Study Completion Date :

Apr 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 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 Test: maximum 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.
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 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 Test: maximum 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.

Arm

Intervention/Treatment

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

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 Test: maximum 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.

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

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 Test: maximum exercise testing

Outcome Measures

Primary Outcome Measures

Forced Vital Capacity (FVC in L) at rest. [1 day]
spirometry at rest

Secondary Outcome Measures

Forced Expiratory Volume [1 day]
FEV1 (in L)
Peak Flow [1 day]
PF (peak flow in L/s)
mean flow rates [1 day]
mean expiratory flow rates in L/ s at 75%, 50% and 25% of FVC (MEF 75, MEF 50, MEF 25).
maximal ventilation [1 day]
VE (ventilation in L/min)
carbon dioxide production [1 day]
VCO2 ( in L/min)
oxygen consumption [1 day]
VO2 ( in L/min)
tidal volume [1 day]
VT (in L)
breathing frequency [1 day]
RF (in breaths/min)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

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:

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