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Adapted Physical Activity Program After Sleeve Gastrectomy (PEEPSO)

L

Lille Catholic University

Status

Withdrawn

Conditions

Obesity

Treatments

Other: Personalized Physical Activity

Study type

Interventional

Funder types

Other

Identifiers

NCT02333903
RC-P0030

Details and patient eligibility

About

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

Full 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.

Sex

Female

Ages

25 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Personalized Physical Activity
Experimental group
Description:
Patients will undergo a personalized physical activity program after sleeve gastrectomy.
Treatment:
Other: Personalized Physical Activity
Regular Activity
No Intervention group
Description:
Patients will have regular physical activity after sleeve gastrectomy.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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