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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03325764
Acronym
FAMOUS
Enrollment
27
Registered
2017-10-30
Start date
2017-11-02
Completion date
2019-11-05
Last updated
2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleeve Gastrectomy

Keywords

Obesity, bariatric surgery, sleeve gastrectomy, physical activity, movement analysis

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).

Interventions

assessment of functional capacity, habitual physical, cardiorespiratory fitness, muscle power and postural stability and gait parameters

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Longitudinal study comparing data before bariatric surgery and one year after bariatric surgery

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
functional capacitybefore and 6 months after sleeve gastrectomyDifference in functional capacity (6-min walk test distance)

Secondary

MeasureTime frameDescription
habitual physical activity (Actigraph GT3X® and activPAL®)before and 6 months after sleeve gastrectomyDifference in habitual physical activity
cardiorespiratory fitness ( cycle ergometer )before and 6 months after sleeve gastrectomyDifference in cardiorespiratory fitness
muscle strength ( isokinetic dynamometer (Contrex®))before and 6 months after sleeve gastrectomyDifference in muscle strength

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026