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

Not Applicable

Completed

• Conditions: Sleeve Gastrectomy
• Interventions: Other: functional assessment

• Registration Number: NCT03325764
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-30
• Study Start: 2017-11-02
• Primary Completion: 2019-11-05
• Study Completion: 2019-11-05
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-24
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sleeve gastrectomy	functional assessment	Assessment before and after sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
functional capacity	before and 6 months after sleeve gastrectomy	Difference in functional capacity (6-min walk test distance)

Secondary Outcome Measures

Name	Time	Method
cardiorespiratory fitness ( cycle ergometer )	before and 6 months after sleeve gastrectomy	Difference in cardiorespiratory fitness
muscle strength ( isokinetic dynamometer (Contrex®))	before and 6 months after sleeve gastrectomy	Difference in muscle strength
habitual physical activity (Actigraph GT3X® and activPAL®)	before and 6 months after sleeve gastrectomy	Difference in habitual physical activity

Trial Locations

Locations (1)

GH-Pitié-Salpêtrière; 🇫🇷 Paris, France