ObesityPEEPSONCT02333903
Adapted Physical Activity Program After Sleeve Gastrectomy
A study testing Personalized Physical Activity in people with Obesity, run by Lille Catholic University at 1 site in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Personalized Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jul 2017
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Obesity
- Being tested
- Personalized Physical Activity
- Keywords
- Obesity, Sleeve gastrectomy, Personalized physical activity program, Body Composition, Fat mass, Lean mass
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Physical ActivityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Physical Activity | Experimental | Patients will undergo a personalized physical activity program after sleeve gastrectomy. Receives: Other: Personalized Physical Activity |
| Regular Activity | No intervention | Patients will have regular physical activity after sleeve gastrectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the ratio of lean mass losses over total body mass losses
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
Measured: 1 month, 6 months, 12 months after surgery
Secondary outcomes (18)
Changes in systolic blood pressure
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the Body Mass Index (BMI)
Anthropometric measures to estimate body Mass Index (BMI).
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes in the lipid profile
(total cholesterol, LDL HDL, Triglycerides)
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of glycemia values
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of HbA1C values
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of albuminemia values
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of insulinemia values
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of creatinemia values
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the body composition analysis with segmental analysis
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
Measured: 1 month, 6 months, 12 months after surgery
Change in the qualitative evaluation of physical activity.
Daily physical activity will be evaluated by a self-questionary (IPAQ)
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the quantitative evaluation of physical activity.
Daily physical activity will be evaluated by accelerometer measurements.
Measured: 1 month, 6 months and 12 months after surgery
Sub-maximal stress testing
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the quantitative evaluation of the sleep quality
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.
Measured: Before and 12 months after surgery
Change in the qualitative evaluation of the sleep quality
Comparison of the sleep quality by the mean of a visual analogic scale in a sleep diary
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the energy balance
Energy balance analysis (energy intake vs energy expenditure) and detailed nutriments analysis.
Measured: 1 month, 6 months, 12 months after surgery
Change in the 6 min Walking test
Determination of the maximal walking distance performed by the patient after a 6 minutes walk
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the quantitative self esteem evaluation
Rosenberg questionary for the evaluation of Self-esteem
Measured: 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
Medical Outcome Study Short Form-36 (MOS SF-36) questionary
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Lille
- Responsible party
- Sponsor
- Investigators
- Antoine Cracco, MD, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333903
- Sponsor's protocol ID
- RC-P0030
- Acronym
- PEEPSO
- Status last verified
- Jan 2015
- First submitted
- 29 Dec 2014
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Adapted Physical Activity Program on Health and Physical Condition After Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02333903
- Acronym / sponsor ID
- PEEPSO / RC-P0030
- Conditions
- Obesity
- Keywords
- Obesity, Sleeve gastrectomy, Personalized physical activity program, Body Composition, Fat mass, Lean mass
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Université de Lille
- Study start
- Jan 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Physical Activity | Experimental | Other: Personalized Physical ActivityPatients will undergo a personalized physical activity program after sleeve gastrectomy. |
| Regular Activity | No intervention | –Patients will have regular physical activity after sleeve gastrectomy. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Physical Activity1.5 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. | Other | Personalized Physical Activity |
Primary outcome
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
18 secondary outcomes
Changes in systolic blood pressure
Time frame: 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
Changes in the lipid profile
Time frame: 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
Changes of HbA1C values
Time frame: 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
Changes of insulinemia values
Time frame: 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
Change in the body composition analysis with segmental analysis
Time frame: 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
Change in the quantitative evaluation of physical activity.
Time frame: 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
Change in the quantitative evaluation of the sleep quality
Time frame: 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
Change in the energy balance
Time frame: 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
Change in the quantitative self esteem evaluation
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Cracco, MD principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Physical Activity in people with Obesity, run by Lille Catholic University 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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 28 Jul 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in the ratio of lean mass losses over total body mass losses (time frame: 1 month, 6 months, 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2015.