Water Exercise and Health (WATHEALTH)

Overweight Clinical Trial

— WATHEALTH  

Official title:

Effect of Water Temperature on Energy Response During Aquatic Cycling in Women: Impact of Weight Status

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
• 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
• 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

Related Conditions & MeSH terms

• Hunger
• Overweight

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