- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03978975
Water Exercise and Health (WATHEALTH) (WATHEALTH)
Effect of Water Temperature on Energy Response During Aquatic Cycling in Women: Impact of Weight 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 40 min.
Subjects will be submitted to three aquatic cycling exercise session:
- session 27°C :aquatic cycling at 27°C without water jet during 40 min
- session 27°C+ water jets : aquatic cycling at 27 °C with water jets during 40 min
- session 18°C : aquatic cycling at 187°C without water jet during 40 min Every exercise session will be set at 70% of theorical maximal heart rate During each session, oxygen consumption and carbon dioxide production will be analysed with gas analysis system. 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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-
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Clermont-Ferrand, France, 63000
- Recruiting
- CHU Clermont-Ferrand
-
Contact:
- Lise Laclautre
- Email: drci@chu-clermontferrand.fr
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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 20 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 |
|---|---|
|
Active Comparator: normal weight women
20 women with a body mass index ranging between 18,5 and 24,9 kg.m2
|
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 40 min. Subjects will be submitted to three aquatic cycling exercise session:
|
|
Experimental: overweight women
20 women with a body mass index ranging between 25 and 29,9 kg.m2
|
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 40 min. Subjects will be submitted to three aquatic cycling exercise session:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food intake during buffet meal 30 minutes after the end of experimental session
Time Frame: Day 7
|
total energy intake at the post session lunch will be calculated by measuring food intake
|
Day 7
|
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Food intake during buffet meal 30 minutes after the end of experimental session
Time Frame: Day 14
|
total energy intake at the post session lunch will be calculated by measuring food intake
|
Day 14
|
|
Food intake during buffet meal 30 minutes after the end of experimental session
Time Frame: Day 21
|
total energy intake at the post session lunch will be calculated by measuring food intake
|
Day 21
|
|
Food intake during buffet meal 30 minutes after the end of experimental session
Time Frame: Day 28
|
total energy intake at the post session lunch will be calculated by measuring food intake
|
Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appetite, hunger and satiety
Time Frame: Day 7
|
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
|
Day 7
|
|
Appetite, hunger and satiety
Time Frame: Day 14
|
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
|
Day 14
|
|
Appetite, hunger and satiety
Time Frame: Day 21
|
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
|
Day 21
|
|
Appetite, hunger and satiety
Time Frame: Day 28
|
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
|
Day 28
|
|
Energy expenditure
Time Frame: Day 7
|
with a gas analyser energy expenditure will be measured in kcal
|
Day 7
|
|
Energy expenditure
Time Frame: Day 14
|
with a gas analyser energy expenditure will be measured in kcal
|
Day 14
|
|
Energy expenditure
Time Frame: Day 21
|
with a gas analyser energy expenditure will be measured in kcal
|
Day 21
|
|
Energy expenditure
Time Frame: Day 28
|
with a gas analyser energy expenditure will be measured in kcal
|
Day 28
|
|
Perceived exertion
Time Frame: Day 7
|
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
|
Day 7
|
|
Perceived exertion
Time Frame: Day 14
|
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
|
Day 14
|
|
Perceived exertion
Time Frame: Day 21
|
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
|
Day 21
|
|
Perceived exertion
Time Frame: Day 28
|
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
|
Day 28
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBHP 2018 DUCLOS 4 (Wathealth)
- 2019-A00353-54 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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