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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Fitness, Physical Activity and Movement Analysis in Obese Patients Undergoing Bariatric Surgery

Conditions
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Sleeve Gastrectomy

Intervention / Treatment
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* Other: functional assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Longitudinal study comparing data before bariatric surgery and one year after bariatric surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: sleeve gastrectomy<br>Assessment before and after sleeve gastrectomy | Other: functional assessment<br>* assessment of functional capacity, habitual physical, cardiorespiratory fitness, muscle power and postural stability and gait parameters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional capacity | Difference in functional capacity (6-min walk test distance) | before and 6 months after sleeve gastrectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| habitual physical activity (Actigraph GT3X® and activPAL®) | Difference in habitual physical activity | before and 6 months after sleeve gastrectomy | 
| cardiorespiratory fitness ( cycle ergometer ) | Difference in cardiorespiratory fitness | before and 6 months after sleeve gastrectomy | 
| muscle strength ( isokinetic dynamometer (Contrex®)) | Difference in muscle strength | before and 6 months after sleeve gastrectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, bariatric surgery, sleeve gastrectomy, physical activity, movement analysis