Fitness, Physical Activity and Movement Analysis in Obese Patients Undergoing Bariatric Surgery (FAMOUS)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Sleeve Gastrectomy

Treatments: Other: functional assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT03325764

2017-A01807-46 (Other Identifier)

HAO 017013

Details and patient eligibility

About

This study aims to describe the effects of sleeve gastrectomy, the most commonly performed bariatric procedure worldwide, on functional capacity, habitual physical activity, physical fitness (cardiorespiratory and muscular fitness) and gait parameters in severely obese subjects undergoing bariatric surgery. Functional capacity, physical activity, physical fitness and gait parameters will be objectively assessed and compared among candidates seeking sleeve gastrectomy and 6 months after sleeve gastrectomy.

Full description

This study is a monocentric longitudinal study conducting in obese patients: candidates to sleeve gastrectomy and these same patients 6 months after.The primary aim of this study is to describe the effects of sleeve gastrectomy on habitual physical activity, physical fitness (cardiorespiratory and muscular fitness) and gait parameters in severely obese patients. Functional capacity will be assessed during a 6-min walk test, habitual physical activity with accelerometers during 7-day recordings in habitual life conditions (Actigraph GT3X® and activPAL®), cardiorespiratory fitness during a maximal exercise test on a cycle ergometer with a direct measure of peakVO2, muscle strength with an isokinetic dynamometer (Contrex®), muscle power and postural stability with force platforms (Kistler® and Satel®) and gait parameters with a gait analysis system (GaitRite®). Fatigue, quality of life and joint pain will be assessed with questionnaires (MFI-20, SF36 and WOMAC, respectively).

Enrollment: 27 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female gender
• Age between 18 and 65 years
• Planned obesity treatment by sleeve gastrectomy
• Patient with massive obesity (BMI ≥ 40 kg/m2) or severe obesity (BMI between 35 and 40 kg/m2) with comorbidities
• Written informed consent

Exclusion criteria

• Subject not affiliated with a social security scheme
• Regular follow-up not feasible
• Participation in a structured physical activity program
• Severe orthopedic problems
• Disabling neuropathy
• Recent (< 6 months) coronary event
• Abnormal cardiac stress test
• Pregnancy

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

sleeve gastrectomy

Other group

Description:

Assessment before and after sleeve gastrectomy

Treatment:

Other: functional assessment