Physical Activity and Bariatric Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-23

Study Completion Date

2021-06-07

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is an open-label, randomized, single-center trial with two groups: an Adapted Physical Activity group and a control group performing no controlled physical activity within each group women undergoing bypass or sleeve surgery

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Adapted Physical Activity Group

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.

Group Type EXPERIMENTAL

Physical activity

Intervention Type OTHER

Between V1 and V2 (i.e. 12 weeks), the APAG (Adapted Physical Activity Group) will participate at a physical training program, 3 sessions of 1h30 per week consisting of endurance activities (60-75% of VO2 peak) and muscle strengthening while the CG will not perform any controlled physical training program. Then, between V2 and V3, no APA (Adapted Physical Activity) program will be offered to both groups.

Control group

Patients will receive standard hospital management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical activity

Between V1 and V2 (i.e. 12 weeks), the APAG (Adapted Physical Activity Group) will participate at a physical training program, 3 sessions of 1h30 per week consisting of endurance activities (60-75% of VO2 peak) and muscle strengthening while the CG will not perform any controlled physical training program. Then, between V2 and V3, no APA (Adapted Physical Activity) program will be offered to both groups.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No