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

NCT ID: NCT03325764

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-02
• Study Completion Date: 2019-11-05

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).

Conditions

Sleeve Gastrectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

sleeve gastrectomy

Assessment before and after sleeve gastrectomy

Group Type: OTHER

functional assessment

Intervention Type: OTHER

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

Interventions

functional assessment

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GH-Pitié-Salpêtrière

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32218061 (View on PubMed)

Other Identifiers

2017-A01807-46

Identifier Type: OTHER

Identifier Source: secondary_id

HAO 017013

Identifier Type: -

Identifier Source: org_study_id