- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02895217
Aquatic Exercise and Metabolism in Women
Evaluation of Energy Balance During Aquatic Cycling Exercise in Premenopausal Women: Effect of Body Composition Status
Study Overview
Detailed Description
After inclusion visit, all subject will be submitted to DXA to obtain body composition data. Then subjects will be submitted to four experimental session in a semi-randomized order. For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session.
Control session (CON): subject will stand sited without any activity during 30 min.
Water exercise session (WAT): subject will exercise on an immersed ergocycle during 30 min at 50 rpm.
Dryland session 1 (LAND-1): subject will exercise on dryland, on the same ergocycle than in WAT session, during 30 min at 50 rpm.
Dryland session 2 (LAND-2): subject will exercise on dryland on the same ergocycle than in WAT. Intensity of exercise will be set at the same heart rate average than in WAT session, exercise will be stopped when subject will have reached the same energy expenditure than during WAT session.
During each session, energy expenditure, heart rate and rate of perceived exertion will be measured at 15 min and 30min.
Appetite and hunger sensation will be measured with a specific scale at different time point of each day of experimental session. Thirty minutes after the end of each experimental session subjects will have a buffet meal for lunch time.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Clermont-Ferrand, France, 63003
- Recruiting
- CHU Clermont-Ferrand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women aged between 23 and 40 years
- BMI under 25kg.m2 for normal weight women and between 25 and 29,9 kg.m2 for overweight women
- Daily breakfast
- Subject which approved informed consent
- Subject with French medical affiliation
Exclusion Criteria:
- Specific medical treatment
- Aquaphobia
- Subject under specific diet regimen or weight loss program
- Subject with cardio-vascular disease
- Surgical intervention less than 3 months
- Subject refusing informed and written consent
- Subject without French medical affiliation
- subject refusing inscription to the national voluntary list
- subject being in an exclusion period
- subject smoking or drinking alcohol frequently
- subject with intense physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cycling exercise in water
The aim of this project is to investigate energetic response (energy expenditure and food intake) of a single bout of cycling exercise in water vs on dryland in normal weight and overweight premenopausal women.
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|
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Experimental: cycling exercise on dryland
The aim of this project is to investigate energetic response (energy expenditure and food intake) of a single bout of cycling exercise in water vs on dryland in normal weight and overweight premenopausal women.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food intake during buffet meal
Time Frame: at day 1
|
during buffet meal 30 min after the end of each experimental session
|
at day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appetite sensation
Time Frame: at day 1
|
during each session (before and after breakfast, before and after experimental session, 30 min after the experimental session, 30min after the end of buffet meal at lunch time) .
Each sensation is measured with a visual analogue scale
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at day 1
|
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Energy expenditure in kcal
Time Frame: at day 1
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during each session (during each 30min session measured by indirect calorimetry)
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at day 1
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Rate of perceived exertion
Time Frame: at day 1
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during each session
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at day 1
|
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hunger sensation
Time Frame: at day 1
|
during each session( before and after breakfast, before and after experimental session, 30 min after the experimental session, 30min after the end of buffet meal at lunch time)
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at day 1
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHU-0272
- 2016-A00197-44 (Other Identifier: 2016-A00197-44)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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