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

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.

Study Overview

• Status: Completed
• Conditions: Ventilation; Exercise
• Intervention / Treatment: Diagnostic test: resting standard spirometry; Diagnostic test: maximum exercise testing

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Vital Capacity (FVC in L) at rest.	spirometry at rest	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
carbon dioxide production	VCO2 ( in L/min)	1 day
breathing frequency	RF (in breaths/min)	1 day
Forced Expiratory Volume	FEV1 (in L)	1 day
Peak Flow	PF (peak flow in L/s)	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).	1 day
maximal ventilation	VE (ventilation in L/min)	1 day
oxygen consumption	VO2 ( in L/min)	1 day
tidal volume	VT (in L)	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Marie Agnes Giroux-Metges, Pr, CHRU de Brest

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Actual): April 18, 2019
• Study Completion (Actual): April 18, 2019

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: lung function; spirometry; pulmonary function; oxygen uptake; cardiopulmonary exercise testing; windsurfer; wetsuit
• Other Study ID Numbers: 29BRC17.0233

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No