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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03978975
Other study ID # RBHP 2018 DUCLOS 4 (Wathealth)
Secondary ID 2019-A00353-54
Status Recruiting
Phase N/A
First received
Last updated
Start date September 19, 2019
Est. completion date January 19, 2022

Study information

Verified date September 2019
Source University Hospital, Clermont-Ferrand
Contact LISE LACLAUTRE
Phone +33473754963
Email drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aquatic cycling is becoming more popular as it appears to be more suitable for men and women even with poor physical activity level. Commercial tagline highlight beneficial effect of this activity on weight management. However there are poor information concerning the energy response induced by this activity. The aim of this project is to investigate effect of water temperature on energetic response (energy expenditure and food intake) of cycling exercise in water in normal weight and overweight premenopausal women.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date January 19, 2022
Est. primary completion date December 19, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Food intake
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.

Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Aquafit Technology, SSR Obésité Nutrition UGECAM

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Food intake during buffet meal 30 minutes after the end of experimental session total energy intake at the post session lunch will be calculated by measuring food intake Day 7
Primary Food intake during buffet meal 30 minutes after the end of experimental session total energy intake at the post session lunch will be calculated by measuring food intake Day 14
Primary Food intake during buffet meal 30 minutes after the end of experimental session total energy intake at the post session lunch will be calculated by measuring food intake Day 21
Primary Food intake during buffet meal 30 minutes after the end of experimental session total energy intake at the post session lunch will be calculated by measuring food intake Day 28
Secondary Appetite, hunger and satiety using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation) Day 7
Secondary Appetite, hunger and satiety using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation) Day 14
Secondary Appetite, hunger and satiety using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation) Day 21
Secondary Appetite, hunger and satiety using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation) Day 28
Secondary Energy expenditure with a gas analyser energy expenditure will be measured in kcal Day 7
Secondary Energy expenditure with a gas analyser energy expenditure will be measured in kcal Day 14
Secondary Energy expenditure with a gas analyser energy expenditure will be measured in kcal Day 21
Secondary Energy expenditure with a gas analyser energy expenditure will be measured in kcal Day 28
Secondary Perceived exertion using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult) Day 7
Secondary Perceived exertion using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult) Day 14
Secondary Perceived exertion using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult) Day 21
Secondary Perceived exertion using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult) Day 28
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