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

Sleeve Gastrectomy Clinical Trial

— FAMOUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03325764
• Other study ID #: HAO 017013
• Secondary ID: 2017-A01807-46
• Status: Completed
• Phase: N/A
• Start date: November 2, 2017
• Est. completion date: November 5, 2019

Study information

• Verified date: January 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 5, 2019
• Est. primary completion date: November 5, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleeve Gastrectomy

Intervention

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

Locations

Country	Name	City	State
France	GH-Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional capacity	Difference in functional capacity (6-min walk test distance)	before and 6 months after sleeve gastrectomy
Secondary	habitual physical activity (Actigraph GT3X® and activPAL®)	Difference in habitual physical activity	before and 6 months after sleeve gastrectomy
Secondary	cardiorespiratory fitness ( cycle ergometer )	Difference in cardiorespiratory fitness	before and 6 months after sleeve gastrectomy
Secondary	muscle strength ( isokinetic dynamometer (Contrex®))	Difference in muscle strength	before and 6 months after sleeve gastrectomy