Aquatic Exercise and Metabolism in Women

Aquacycling Clinical Trial

Official title:

Evaluation of Energy Balance During Aquatic Cycling Exercise in Premenopausal Women: Effect of Body Composition Status

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02895217
• Other study ID #: CHU-0272
• Secondary ID: 2016-A00197-44
• Status: Recruiting
• Phase: N/A
• First received: July 12, 2016
• Last updated: September 5, 2016
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: September 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Exercise training on an immersible ergocycle 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 23 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aquacycling

Intervention

Other:
• ergocycle

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (1)

Bréchat PH, Wolf JP, Simon-Rigaud ML, Bréchat N, Kantelip JP, Berthelay S, Regnard J. Influence of immersion on respiratory requirements during 30-min cycling exercise. Eur Respir J. 1999 Apr;13(4):860-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food intake during buffet meal	during buffet meal 30 min after the end of each experimental session	at day 1	Yes
Secondary	Appetite sensation	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	at day 1	Yes
Secondary	Energy expenditure in kcal	during each session (during each 30min session measured by indirect calorimetry)	at day 1	Yes
Secondary	Rate of perceived exertion	during each session	at day 1	Yes
Secondary	hunger sensation	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)	at day 1	Yes