AzTrials
AzTrials

Sleeve GastrectomyFAMOUSNCT03325764

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

A study testing functional assessment in people with Sleeve Gastrectomy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Sleeve Gastrectomy
What is being tested?
functional assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteFrance
Study dates
2 Nov 2017to 5 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • GH-Pitié-Salpêtrière

    Paris, 75013

Other trials in France

About this study

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.

Read the 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).

Being tested
functional assessment
Keywords
Obesity, bariatric surgery, sleeve gastrectomy, physical activity, movement analysis
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • functional assessmentOther

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

Study groups in NCT03325764
Study groupRoleWhat they receive
sleeve gastrectomyOtherAssessment before and after sleeve gastrectomy
Receives: Other: functional assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. functional capacity

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

    Measured: before and 6 months after sleeve gastrectomy

Secondary outcomes (3)

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

    Difference in habitual physical activity

    Measured: before and 6 months after sleeve gastrectomy

  2. cardiorespiratory fitness ( cycle ergometer )

    Difference in cardiorespiratory fitness

    Measured: before and 6 months after sleeve gastrectomy

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

    Difference in muscle strength

    Measured: before and 6 months after sleeve gastrectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2017
  2. Study start2 Nov 2017
  3. Primary completion5 Nov 2019
  4. Study completion5 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Longitudinal study comparing data before bariatric surgery and one year after bariatric surgery
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03325764
Sponsor's protocol ID
HAO 017013
Other IDs
2017-A01807-46
Acronym
FAMOUS
Status last verified
Jan 2021
First submitted
12 Oct 2017
Last updated
26 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32218061

Questions about this trial

What is this clinical trial studying?

A study testing functional assessment in people with Sleeve Gastrectomy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

functional capacity (time frame: before and 6 months after sleeve gastrectomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03325764, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in