Physical Activity and Bariatric Surgery (ACTIBARIA)

Centre Hospitalier Régional d'Orléans

Status: Completed

Conditions: Bariatric Surgery Candidate

Treatments: Other: Physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT05050968

CHRO-2016-03

Details and patient eligibility

About

Bariatric surgery indeed leads to significant weight loss, reduces mortality risk, obesity-associated comorbidities (Wolfe et al., 2016) and improves functional physical abilities (Herring et al., 2016). Because these benefits are related to decreased energy intake, the investigators aim to optimize them by combining them with supervised adapted physical activity practice.

So, the aim of this clinical trial is to measure the effects of a physical training program on physical fitness, body composition and quality of life of obese women who have undergone bariatric surgery.

Full description

Upon hospitalization for their bariatric surgery (bypass or sleeve), subjects will sign their informed consent and be included in the study. Six weeks' post-surgery, the subjects will be randomized in one of the 2 groups (Control group CG or Adapted Physical Activity group APAG). Patients in both groups will have 3 postoperative visits one at 6 weeks (V1), one at 18 weeks (V2) and one at 30 weeks (V3). During these visits, they will undergo the same assessments (body composition, physical condition, quality of life). Patients in the CG will receive standard hospital management. Patients in APAG will follow the same management and will also follow a 3-month physical activity program 3 times a week between V1 and V2. Then, between V2 and V3, no APA program will be offered to both groups.

The subjects will evaluate during each visit V1, V2 and V3:

• body composition,
• physical condition,
• quality of life
• daily physical activity

Enrollment: 37 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women between 18 and 55 years old
• undergoing bariatric surgery (a "bypass gastric" or a "sleeve")
• not practicing a supervised physical activity
• having read and signed an informed consent prior to the start of the trial
• being affiliated to a social security system

Exclusion criteria

• Women with a contraindication to physical activity
• any medical contraindication to the practice of stress tests.
• unable to go to the hospital regularly
• having a significant functional limitation that does not allow her to perform the 6-minute walk test
• with an intellectual disability and/or psychiatric illness
• does not speak and/or understand French
• pregnant woman
• under guardianship or curatorship
• participating in another clinical research

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Adapted Physical Activity Group

Experimental group

Description:

Patients will follow a 3-month physical activity program 3 times a week between V1 and V2. Then, between V2 and V3, no APA program will be offered to both groups.

Treatment:

Other: Physical activity

Control group

No Intervention group

Description:

Patients will receive standard hospital management