Adapted Physical Activity Program After Sleeve Gastrectomy

NCT ID: NCT02333903

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-07-31

Brief 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

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Personalized Physical Activity

Patients will undergo a personalized physical activity program after sleeve gastrectomy.

Group Type: EXPERIMENTAL

Personalized Physical Activity

Intervention Type: OTHER

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.

Regular Activity

Patients will have regular physical activity after sleeve gastrectomy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Université de Lille

OTHER

Sponsor Role: collaborator

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine Cracco, MD

Role: PRINCIPAL_INVESTIGATOR

Groupement des Hôpitaux de l'Institut Catholique de Lille

Locations

Hopital Saint Philibert

Lomme, , France

Countries

France

Other Identifiers

RC-P0030

Identifier Type: -

Identifier Source: org_study_id