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OpenTrials
Completed

NCT Number: NCT03325764

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GH-Pitié-Salpêtrière

Paris, 75013, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

functional assessment

Other

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

Primary outcomes

  1. functional capacity

    Time frame: before and 6 months after sleeve gastrectomy

    Difference in functional capacity (6-min walk test distance)

Secondary outcomes

  1. habitual physical activity (Actigraph GT3X® and activPAL®)

    Time frame: before and 6 months after sleeve gastrectomy

    Difference in habitual physical activity

  2. cardiorespiratory fitness ( cycle ergometer )

    Time frame: before and 6 months after sleeve gastrectomy

    Difference in cardiorespiratory fitness

  3. muscle strength ( isokinetic dynamometer (Contrex®))

    Time frame: before and 6 months after sleeve gastrectomy

    Difference in muscle strength

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: FAMOUS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2017
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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