Adapted Physical Activity Program After Sleeve Gastrectomy (PEEPSO)

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

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

Study Overview

• Status: Withdrawn
• Conditions: Obesity
• Intervention / Treatment: Other: Personalized Physical Activity

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lomme, France, 59462
    • Hôpital Saint Philibert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized Physical Activity; Patients will undergo a personalized physical activity program after sleeve gastrectomy.	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.
No Intervention: Regular Activity; Patients will have regular physical activity after sleeve gastrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in systolic blood pressure		1 month, 3 months, 6 months, 9 months and 12 months after surgery
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
Changes in the lipid profile	(total cholesterol, LDL HDL, Triglycerides)	1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of glycemia values		1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of HbA1C values		1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of albuminemia values		1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of insulinemia values		1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of creatinemia values		1 month, 3 months, 6 months, 9 months and 12 months after surgery
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
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
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
Sub-maximal stress testing		1 month, 3 months, 6 months, 9 months and 12 months after surgery
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Collaborators: Université de Lille
• Investigators: Principal Investigator: Antoine Cracco, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: December 29, 2014
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Obesity; Body Composition; Sleeve gastrectomy; Lean mass; Fat mass; Personalized physical activity program
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: RC-P0030