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NCT Number: NCT06597617

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

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.

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Key information

Conditions

Obesity Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Adapted physical activity with aerobic training [GEA]

Behavioral

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]

Behavioral

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.

Primary outcomes

  1. 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.

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

  2. Blood concentration for each POP investigated

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

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

Secondary outcomes

  1. Total POPs blood concentration [∑POPs]

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

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

  2. Quantity by POPs category

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

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

  3. Specific and relative muscle strength

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

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

  4. M-wave

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

    M-wave will be obtained using an EMG device.

  5. NAV [Voluntary Activation Level]

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

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

  6. Fatigability

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

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

  7. Pennation angle

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

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

  8. Muscle thickness

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

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

  9. Fascicle length

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

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

  10. Characterization of gut microbiota

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

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

  11. Weight

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

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

  12. Fat mass

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

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

  13. Lean mass

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

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

  14. Body mass index (BMI)

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

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

  15. Waist-to-hip ratio

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

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

  16. Total cholesterol

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

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

  17. Free cholesterol

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

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

  18. Total intra-serum lipids

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

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

  19. Phospholipids

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

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

  20. Triglycerides

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas CHEVALIER, Pr

CONTACT

[email protected]

04 92 03 67 55 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: PERSIST-APA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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