Adapted Physical Activity Program After Sleeve Gastrectomy (PEEPSO)

July 27, 2015 updated by: Lille Catholic University

Effects of an Adapted Physical Activity Program on Health and Physical Condition After Sleeve Gastrectomy

This study compares the ratio of lean mass losses over total body mass losses between patients undergoing sleeve gastrectomy followed by physical activity training versus patients undergoing sleeve gastrectomy only

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will assess prospectively and objectively the potential benefits of a personalized and specific rehabilitation program designed for patients who undergone sleeve gastrectomy. This strategy will help to reduce fat mass and to limit lean mass loss, in order to prevent in the short term the overweight recurrence. Also,the improvement of physical and metabolic status is expected.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lomme, France, 59462
        • Hôpital Saint Philibert

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • BMI >40 kg/m² or BMI>35kg/m² with comorbidities qualifying for bariatric surgery
  • Stable obesity or obesity evolving for more than 5 years
  • Patient cleared by the surgeon for sleeve gastrectomy one month before recruitment
  • Absence of contraindication for a sub-maximal stress test
  • Performance of a polysomnography before surgery
  • Signed informed consent
  • Patient benefiting from Health Care Coverage

Exclusion Criteria:

  • Absence of preliminary and regular medical check-ups mandatory before sleeve gastrectomy
  • Anticipated difficulty for patient follow-up
  • Mental diseases (psychosis, depression, suicidal behavior or history)
  • Eating disorders
  • Lack of informed consent or cooperation
  • Unsufficient patient commitment
  • Patient under judiciary protection
  • Patient not able to comply with any or all the research procedures over time including physical activity
  • Patient excluded from the french database of volunteers for clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Personalized Physical Activity
Patients will undergo a personalized physical activity program after sleeve gastrectomy.
Other: Personalized Physical Activity

1.5 hours physical training sessions, twice a week for 1 year, under the supervision of a dedicated coach specialized in supporting overweighted patients.

Typical training session organized for small groups (5 patients) will consist of aerobic exercises, muscular strengthening (4 peripheral members and abdominal muscular belt), followed by stretching exercises.
No Intervention: Regular Activity
Patients will have regular physical activity after sleeve gastrectomy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the ratio of lean mass losses over total body mass losses
Time Frame: 1 month, 6 months, 12 months after surgery
Percentage of lean mass loss compared to total body weight loss measured with bioimpedancemetry and dual energy X-Rays absorptiometry (DXA) at 1, 6 and 12 months after surgery
1 month, 6 months, 12 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in systolic blood pressure
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the Body Mass Index (BMI)
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Anthropometric measures to estimate body Mass Index (BMI).
1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes in the lipid profile
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
(total cholesterol, LDL HDL, Triglycerides)
1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of glycemia values
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of HbA1C values
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of albuminemia values
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of insulinemia values
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of creatinemia values
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the body composition analysis with segmental analysis
Time Frame: 1 month, 6 months, 12 months after surgery
Main parameter: Percentage of lean mass loss compared to total body weight loss measured with bioimpedancemetry at at 1, 6 and 12 months after surgery
1 month, 6 months, 12 months after surgery
Change in the qualitative evaluation of physical activity.
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Daily physical activity will be evaluated by a self-questionary (IPAQ)
1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the quantitative evaluation of physical activity.
Time Frame: 1 month, 6 months and 12 months after surgery
Daily physical activity will be evaluated by accelerometer measurements.
1 month, 6 months and 12 months after surgery
Sub-maximal stress testing
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the quantitative evaluation of the sleep quality
Time Frame: Before and 12 months after surgery
Comparison of sleep quality : micro awakeness index (average number per hour during Rapid Eye Movement (REM) and Non REM phases); index of micro awakeness following an apnea event.
Before and 12 months after surgery
Change in the qualitative evaluation of the sleep quality
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Comparison of the sleep quality by the mean of a visual analogic scale in a sleep diary
1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the energy balance
Time Frame: 1 month, 6 months, 12 months after surgery
Energy balance analysis (energy intake vs energy expenditure) and detailed nutriments analysis.
1 month, 6 months, 12 months after surgery
Change in the 6 min Walking test
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Determination of the maximal walking distance performed by the patient after a 6 minutes walk
1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the quantitative self esteem evaluation
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Rosenberg questionary for the evaluation of Self-esteem
1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the quantitative evaluation of the health related quality of life
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Medical Outcome Study Short Form-36 (MOS SF-36) questionary
1 month, 3 months, 6 months, 9 months and 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lille Catholic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Université de Lille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antoine Cracco, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC-P0030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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