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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03440294
Other study ID # 29BRC17.0233
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 22, 2018
Est. completion date April 18, 2019

Study information

Verified date May 2019
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date April 18, 2019
Est. primary completion date April 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
France University hospital Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Forced Vital Capacity (FVC in L) at rest. spirometry at rest 1 day
Secondary Forced Expiratory Volume FEV1 (in L) 1 day
Secondary Peak Flow PF (peak flow in L/s) 1 day
Secondary 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
Secondary maximal ventilation VE (ventilation in L/min) 1 day
Secondary carbon dioxide production VCO2 ( in L/min) 1 day
Secondary oxygen consumption VO2 ( in L/min) 1 day
Secondary tidal volume VT (in L) 1 day
Secondary breathing frequency RF (in breaths/min) 1 day
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