Clinical trial NCT03325764: Fitness, Physical Activity and Movement Analysis in Obese Patients Undergoing Bariatric Surgery
Official title: Fitness, Physical Activity and Movement Analysis in Obese Patients Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleeve Gastrectomy
Keywords: Obesity
bariatric surgery
sleeve gastrectomy
physical activity
movement analysis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal study comparing data before bariatric surgery and one year after bariatric surgery
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: functional capacity
timeFrame: before and 6 months after sleeve gastrectomy
Secondary outcomes:
measure: habitual physical activity (Actigraph GT3X® and activPAL®)
timeFrame: before and 6 months after sleeve gastrectomy
measure: cardiorespiratory fitness ( cycle ergometer )
timeFrame: before and 6 months after sleeve gastrectomy
measure: muscle strength ( isokinetic dynamometer (Contrex®))
timeFrame: before and 6 months after sleeve gastrectomy
Other outcomes:
Locations:
city: Paris
country: France
facility: GH-Pitié-Salpêtrière
Study officials:
References:
citation: Bellicha A, Giroux C, Ciangura C, Menoux D, Thoumie P, Oppert JM, Portero P. Vertical Jump on a Force Plate for Assessing Muscle Strength and Power in Women With Severe Obesity: Reliability, Validity, and Relations With Body Composition. J Strength Cond Res. 2022 Jan 1;36(1):75-81. doi: 10.1519/JSC.0000000000003432.