Adapted Physical Activity Program After Sleeve Gastrectomy

Obesity Clinical Trial

— PEEPSO  

Official title:

Effects of an Adapted Physical Activity Program on Health and Physical Condition After Sleeve Gastrectomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02333903
• Other study ID #: RC-P0030
• Status: Withdrawn
• Phase: N/A
• First received: December 29, 2014
• Last updated: July 27, 2015
• Start date: January 2015
• Est. completion date: July 2017

Study information

• Verified date: January 2015
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study compares the ratio of lean mass losses over total body mass losses between patients undergoing sleeve gastrectomy followed by physical activity training versus patients undergoing sleeve gastrectomy only

Description:

This study will assess prospectively and objectively the potential benefits of a personalized and specific rehabilitation program designed for patients who undergone sleeve gastrectomy. This strategy will help to reduce fat mass and to limit lean mass loss, in order to prevent in the short term the overweight recurrence. Also,the improvement of physical and metabolic status is expected.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• BMI >40 kg/m² or BMI>35kg/m² with comorbidities qualifying for bariatric surgery

• Stable obesity or obesity evolving for more than 5 years

• Patient cleared by the surgeon for sleeve gastrectomy one month before recruitment

• Absence of contraindication for a sub-maximal stress test

• Performance of a polysomnography before surgery

• Signed informed consent

• Patient benefiting from Health Care Coverage

Exclusion Criteria:

• Absence of preliminary and regular medical check-ups mandatory before sleeve gastrectomy

• Anticipated difficulty for patient follow-up

• Mental diseases (psychosis, depression, suicidal behavior or history)

• Eating disorders

• Lack of informed consent or cooperation

• Unsufficient patient commitment

• Patient under judiciary protection

• Patient not able to comply with any or all the research procedures over time including physical activity

• Patient excluded from the french database of volunteers for clinical trials

Study Design

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Personalized Physical Activity
1.5 hours physical training sessions, twice a week for 1 year, under the supervision of a dedicated coach specialized in supporting overweighted patients. Typical training session organized for small groups (5 patients) will consist of aerobic exercises, muscular strengthening (4 peripheral members and abdominal muscular belt), followed by stretching exercises.

Locations

Country	Name	City	State
France	Hopital Saint Philibert	Lomme

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	Université de Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the ratio of lean mass losses over total body mass losses	Percentage of lean mass loss compared to total body weight loss measured with bioimpedancemetry and dual energy X-Rays absorptiometry (DXA) at 1, 6 and 12 months after surgery	1 month, 6 months, 12 months after surgery	Yes
Secondary	Changes in systolic blood pressure		1 month, 3 months, 6 months, 9 months and 12 months after surgery	No
Secondary	Change in the Body Mass Index (BMI)	Anthropometric measures to estimate body Mass Index (BMI).	1 month, 3 months, 6 months, 9 months and 12 months after surgery	No
Secondary	Changes in the lipid profile	(total cholesterol, LDL HDL, Triglycerides)	1 month, 3 months, 6 months, 9 months and 12 months after surgery	No
Secondary	Changes of glycemia values		1 month, 3 months, 6 months, 9 months and 12 months after surgery	No
Secondary	Changes of HbA1C values		1 month, 3 months, 6 months, 9 months and 12 months after surgery	No
Secondary	Changes of albuminemia values		1 month, 3 months, 6 months, 9 months and 12 months after surgery	No
Secondary	Changes of insulinemia values		1 month, 3 months, 6 months, 9 months and 12 months after surgery	No
Secondary	Changes of creatinemia values		1 month, 3 months, 6 months, 9 months and 12 months after surgery	No
Secondary	Change in the body composition analysis with segmental analysis	Main parameter: Percentage of lean mass loss compared to total body weight loss measured with bioimpedancemetry at at 1, 6 and 12 months after surgery	1 month, 6 months, 12 months after surgery	No
Secondary	Change in the qualitative evaluation of physical activity.	Daily physical activity will be evaluated by a self-questionary (IPAQ)	1 month, 3 months, 6 months, 9 months and 12 months after surgery	No
Secondary	Change in the quantitative evaluation of physical activity.	Daily physical activity will be evaluated by accelerometer measurements.	1 month, 6 months and 12 months after surgery	No
Secondary	Sub-maximal stress testing		1 month, 3 months, 6 months, 9 months and 12 months after surgery	Yes
Secondary	Change in the quantitative evaluation of the sleep quality	Comparison of sleep quality : micro awakeness index (average number per hour during Rapid Eye Movement (REM) and Non REM phases); index of micro awakeness following an apnea event.	Before and 12 months after surgery	No
Secondary	Change in the qualitative evaluation of the sleep quality	Comparison of the sleep quality by the mean of a visual analogic scale in a sleep diary	1 month, 3 months, 6 months, 9 months and 12 months after surgery	No
Secondary	Change in the energy balance	Energy balance analysis (energy intake vs energy expenditure) and detailed nutriments analysis.	1 month, 6 months, 12 months after surgery	No
Secondary	Change in the 6 min Walking test	Determination of the maximal walking distance performed by the patient after a 6 minutes walk	1 month, 3 months, 6 months, 9 months and 12 months after surgery	No
Secondary	Change in the quantitative self esteem evaluation	Rosenberg questionary for the evaluation of Self-esteem	1 month, 3 months, 6 months, 9 months and 12 months after surgery	No
Secondary	Change in the quantitative evaluation of the health related quality of life	Medical Outcome Study Short Form-36 (MOS SF-36) questionary	1 month, 3 months, 6 months, 9 months and 12 months after surgery	No