ClinicalTrials.gg
CompletedNCT03325764FAMOUSUpdated Jan 26, 2021

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

An interventional study of functional assessment in Sleeve Gastrectomy, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-26.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 57 studies in Obesity by Assistance Publique - Hôpitaux de Paris — 15 open to participants now, 15 under way, 1 of them phase 3. Obesity · Assistance Publique - Hôpitaux de Paris.

Enrollment
33rd of 37
27 · median 120
Started
2017
with 2 others
No phase
29 of 57
8 open now
Registered
32nd of 57
by date

Among the 57 studies in Obesity by Assistance Publique - Hôpitaux de Paris, this one is the 33rd largest by enrollment of the 37 interventional ones that give a count, is one of 3 that started in 2017, is one of 29 with no phase, and was the 32nd registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

15 of the 57 studies in Obesity by Assistance Publique - Hôpitaux de Paris are open now, in 1 country. Recruiting first, the newest first:

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By country, each count listing its studies:

All 15 open studies →

Where they have run

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years to 65 Years · female · no healthy volunteers.

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02

Study 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.

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).

03

Conditions studied

  • Sleeve Gastrectomy

Keywords

  • Obesity
  • bariatric surgery
  • sleeve gastrectomy
  • physical activity
  • movement analysis
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female gender
  • Age between 18 and 65 years
  • Planned obesity treatment by sleeve gastrectomy
  • Patient with massive obesity ( ≥ 40 kg/m2) or severe obesity (BMI between 35 and 40 kg/m2) with comorbidities
  • Written

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Other
    sleeve gastrectomy

    Assessment before and after sleeve gastrectomy

    Other: functional assessment

Interventions

  • Otherfunctional assessment

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

06

What researchers measure

Primary outcomes

  1. functional capacity

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

    Time frame: before and 6 months after sleeve gastrectomy

Secondary outcomes

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

    Difference in habitual physical activity

    Time frame: before and 6 months after sleeve gastrectomy

  2. cardiorespiratory fitness ( cycle ergometer )

    Difference in cardiorespiratory fitness

    Time frame: before and 6 months after sleeve gastrectomy

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

    Difference in muscle strength

    Time frame: before and 6 months after sleeve gastrectomy

07

Study locations

1 site
  • GH-Pitié-Salpêtrière
    Paris, 75013, France
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Nov 2019, 24 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 24 months is close to that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2017
First posted
Oct 30, 2017
StartActual
Nov 2, 2017
Primary completionActual
Nov 5, 2019
CompletionActual
Nov 5, 2019
Last update
Jan 26, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03325764
Responsible party
Sponsor
First posted
Oct 30, 2017
Start date
Nov 2, 2017
Primary completion
Nov 5, 2019
Completion
Nov 5, 2019
Last update
Jan 26, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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