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

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.

Study Overview

• Status: Completed
• Conditions: Sleeve Gastrectomy
• Intervention / Treatment: Other: functional assessment

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • GH-Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Actual): November 5, 2019
• Study Completion (Actual): November 5, 2019

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 24, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; Obesity; bariatric surgery; sleeve gastrectomy; movement analysis
• Other Study ID Numbers: HAO 017013; 2017-A01807-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No