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ObesityPERSIST-APANCT06597617

Persistent Organic Pollutants and Mechanical Discharge: Limiting the Impact of Bariatric Surgery Through Personalized Adapted Physical Activity

A study testing Adapted physical activity with aerobic training [GEA] and Adapted physical activity with strength training [GRM] in people with Obesity and Bariatric Surgery Candidate, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

For the most severe cases of obesity, recourse to bariatric surgery is the ultimate solution. Although highly beneficial to individual health, this massive loss of body mass could also have negative effects on metabolism and neuromuscular function. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Obesity, Bariatric Surgery Candidate
What is being tested?
Adapted physical activity with aerobic training [GEA] and Adapted physical activity with strength training [GRM]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
Jun 2025to Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult patient (18-55 years)
  • Patient scheduled for bariatric surgery
  • Patient practicing a leisure-time physical activity < 8 hours of moderate intensity per week or < 4 hours of high intensity per week
  • Presence of effective contraception (hormonal or mechanical)

Who cannot join

  • Patient already involved in another experimental study
  • Pregnant (urine pregnancy test) or breast-feeding women
  • Patient in a particular situation deemed incompatible with the study by the investigator
  • Patients from outside the Alpes-Maritimes and Var departments
  • Patient having received antibiotic treatment during the 3 months preceding the first stool collection
  • Presence of a contraindication to adapted physical activity
  • Presence of a contraindication to neurostimulation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • CHU de Nice

    Nice

    Nicolas CHEVALIER, Pr, 04 92 03 67 55 ext. +33, chevalier.n@chu-nice.fr

    Recruiting

Other trials in France

About this study

For the most severe cases of obesity, recourse to bariatric surgery is the ultimate solution. Although highly beneficial to individual health, this massive loss of body mass could also have negative effects on metabolism and neuromuscular function. Unfortunately, these effects have been relatively little studied in the scientific literature, and are poorly taken into account in patient follow-up when bariatric surgery has been recommended. One of the adverse effects of bariatric surgery is the release into the bloodstream of Persistent Organic Pollutants (POPs) which, are not only persistent, but also bioaccumulative, toxic and mobile. The major problem is that these circulating POPs are linked to a number of adverse side effects, including reproductive disorders, neurobehavioral alterations, metabolic disorders, gut microbiota alterations inflammatory changes and physiological alterations. POP neurotoxicity could also affect psychomotor abilities and neuromuscular function. In addition, the mechanical unloading (i.e., reduced mechanical stress on muscles) induced by loss of body mass, an effect targeted by bariatric surgery and largely beneficial to the health of individuals, could also alter neuromuscular function and potentially alter muscle architecture and contractile properties. Unfortunately, no data are currently available in the scientific literature to confirm or refute these hypotheses. Physical activity-based intervention strategies may be usefull to counteract the effects of mechanical unloading and the release of POPs as suggested in scientific literature. However it is also possible to question which exercise modality should be preferred. Our hypothesis is that eccentric muscle strengthening would better preserve muscle mass and neuromuscular function while limiting the risks associated with POPs release, compared with an aerobic and a control group.

Being tested
Adapted physical activity with aerobic training [GEA], Adapted physical activity with strength training [GRM]
Medical subject headings
Obesity

What participants receive

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

  • Adapted physical activity with aerobic training [GEA]Behavioural

    Participants will be required to take part in 3 weekly sessions of adapted physical activity for 3 months following bariatric surgery. These sessions (not exceeding 1 hour and 10 minutes) will focus on aerobic training. The first 3 sessions will be accompanied, and will take place either by videoconference or face-to-face, depending on the patient's wishes. Thereafter, each 1st session of the following weeks will also be accompanied and carried out either by videoconference or face-to-face. The following 2 sessions of the week will be carried out autonomously.

    Each session will be organized into (i) a 5-minute cardio-respiratory warm-up and joint mobilization, (ii) a block of aerobic activity and (iii) a 2-minute cool-down including breathing exercises. Training will take place in 2 phases. The first phase will involve a total of 90 minutes of aerobic training spread over 3 sessions. The second phase will involve a total of 150 minutes of aerobic training over 3 sessions.

  • Adapted physical activity with strength training [GRM]Behavioural

    Participants will be required to take part in 3 weekly sessions of adapted physical activity for 3 months following bariatric surgery. These sessions (not exceeding 1 hour and 10 minutes) will focus on eccentric training. The first 3 sessions will be accompanied and conducted face-to-face. Thereafter, each 1st session of the following weeks will also be accompanied and carried out face-to-face. The following 2 sessions of the week will be carried out autonomously.

    Each session will be organized into (i) a 5-minute cardio-respiratory warm-up and joint mobilization, (ii) muscle-strengthening exercises and (iii) a 2-minute cool-down including breathing exercises. The exercises used will mainly involve the lower limbs. Training will take place in 2 phases. The first phase will involve an exposure/adaptation phase to eccentric training. The second phase will involve a gradual increase in intensity.

Study groups in NCT06597617
Study groupRoleWhat they receive
Group ControlNo interventionNot described
GEA (Aerobic training)ExperimentalNot described
Receives: Behavioral: Adapted physical activity with aerobic training [GEA]
GRM (Strength training)ExperimentalNot described
Receives: Behavioral: Adapted physical activity with strength training [GRM]

What is being measured

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

  1. MVC (Maximum Voluntary Contraction)

    Unit used to quantify MVC (Maximum Voluntary Contraction): Nm. Description: MVC will be obtained using an ergometer and force sensors.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  2. Blood concentration for each POP investigated

    Unit used to quantify blood concentration for each POP (Persistent Organic Pollutant) investigated: ng/g of lipid.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

Secondary outcomes (20)
  1. Total POPs blood concentration [∑POPs]

    Total POPs blood concentration [∑POPs] (ng/ml) will be obtained with the analysis of a blood sampling by chromatography and spectrometry.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  2. Quantity by POPs category

    Quantity by POPs category (ng/ml) will be obtained with the analysis of a blood sampling by chromatography and spectrometry.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  3. Specific and relative muscle strength

    Specific and relative muscle strength (N m) will be obtained using an ergometer and force sensors.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  4. M-wave

    M-wave will be obtained using an EMG device.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  5. NAV [Voluntary Activation Level]

    NAV [Voluntary Activation Level] (%) will be obtained using an ergometer, force sensors and a stimulator device

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  6. Fatigability

    Fatigability (Δ N m) will be obtained using an ergometer, force sensors and a muscular fatigue protocol.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  7. Pennation angle

    Pennation angle (°) will be obtained by muscle ultrasound imaging.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  8. Muscle thickness

    Muscle thickness (mm) will be obtained by muscle ultrasound imaging.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  9. Fascicle length

    Fascicle length (mm) will be obtained by muscle ultrasound imaging.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  10. Characterization of gut microbiota

    Alpha and beta diversity will be obtained by the analysis of feces collected with specific sampling kit.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  11. Weight

    Weigh (kg) will be obtained by using a weight balance.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  12. Fat mass

    Fat mass (kg and %) will be obtained by using an impedancemeter.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  13. Lean mass

    Lean mass (kg and %) will be obtained by using an impedancemeter.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  14. Body mass index (BMI)

    Body mass index (kg/m^2) will be obtained by using weight balance and a height chart.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  15. Waist-to-hip ratio

    Waist-to-hip ratio will be obtained by measuring the waist circumference (cm) and the hip circumference (cm) with the WHO protocol.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  16. Total cholesterol

    Total cholesterol (g/l) will be obtained with blood sampling analysis.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  17. Free cholesterol

    Free cholesterol (g/l) will be obtained with blood sampling analysis.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  18. Total intra-serum lipids

    Total intra-serum lipids (g/l) will be obtained with blood sampling analysis.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  19. Phospholipids

    Phospholipids (g/l) will be obtained with blood sampling analysis.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

  20. Triglycerides

    Triglycerides (g/l) will be obtained with blood sampling analysis.

    Measured: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

Timeline

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

  1. First posted19 Sep 2024
  2. Study startJun 2025 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionOct 2028 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06597617
Sponsor's protocol ID
24-PP-03
Acronym
PERSIST-APA
Status last verified
Mar 2025
First submitted
17 Jul 2024
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Adapted physical activity with aerobic training [GEA] and Adapted physical activity with strength training [GRM] in people with Obesity and Bariatric Surgery Candidate, run by Centre Hospitalier Universitaire de Nice 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Mar 2025. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Nicolas CHEVALIER, Pr (04 92 03 67 55 ext. +33, chevalier.n@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MVC (Maximum Voluntary Contraction) (time frame: One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.). The study lists 2 primary outcomes in all. 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 25 Mar 2025.

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