Persistent Organic Pollutants and Mechanical Discharge: Limiting the Impact of Bariatric Surgery Through Personalized Adapted Physical Activity (PERSIST-APA)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Bariatric Surgery Candidate
• Intervention / Treatment: Behavioral: Adapted physical activity with aerobic training [GEA]; Behavioral: Adapted physical activity with strength training [GRM]

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas CHEVALIER, Pr; Phone Number: +33 04 92 03 67 55; Email: chevalier.n@chu-nice.fr

Study Locations

• France
  • Nice, France
    • Recruiting
    • CHU de Nice
    • Contact: Nicolas CHEVALIER, Pr; Phone Number: +33 04 92 03 67 55; Email: chevalier.n@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group Control
Experimental: GEA (Aerobic training)	Behavioral: Adapted physical activity with aerobic training [GEA]; 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.
Experimental: GRM (Strength training)	Behavioral: Adapted physical activity with strength training [GRM]; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MVC (Maximum Voluntary Contraction)	Unit used to quantify MVC (Maximum Voluntary Contraction): Nm. Description: MVC will be obtained using an ergometer and force sensors.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
Blood concentration for each POP investigated	Unit used to quantify blood concentration for each POP (Persistent Organic Pollutant) investigated: ng/g of lipid.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Quantity by POPs category (ng/ml) will be obtained with the analysis of a blood sampling by chromatography and spectrometry.	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	Specific and relative muscle strength (N m) will be obtained using an ergometer and force sensors.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
M-wave	M-wave will be obtained using an EMG device.	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]	NAV [Voluntary Activation Level] (%) will be obtained using an ergometer, force sensors and a stimulator device	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
Fatigability	Fatigability (Δ N m) will be obtained using an ergometer, force sensors and a muscular fatigue protocol.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
Pennation angle	Pennation angle (°) will be obtained by muscle ultrasound imaging.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
Muscle thickness	Muscle thickness (mm) will be obtained by muscle ultrasound imaging.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
Fascicle length	Fascicle length (mm) will be obtained by muscle ultrasound imaging.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
Characterization of gut microbiota	Alpha and beta diversity will be obtained by the analysis of feces collected with specific sampling kit.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
Weight	Weigh (kg) will be obtained by using a weight balance.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
Fat mass	Fat mass (kg and %) will be obtained by using an impedancemeter.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
Lean mass	Lean mass (kg and %) will be obtained by using an impedancemeter.	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 (BMI)	Body mass index (kg/m^2) will be obtained by using weight balance and a height chart.	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	Waist-to-hip ratio will be obtained by measuring the waist circumference (cm) and the hip circumference (cm) with the WHO protocol.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
Total cholesterol	Total cholesterol (g/l) will be obtained with blood sampling analysis.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
Free cholesterol	Free cholesterol (g/l) will be obtained with blood sampling analysis.	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	Total intra-serum lipids (g/l) will be obtained with blood sampling analysis.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
Phospholipids	Phospholipids (g/l) will be obtained with blood sampling analysis.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.
Triglycerides	Triglycerides (g/l) will be obtained with blood sampling analysis.	One week prior to bariatric surgery, 1 month after bariatric surgery, 4 months after bariatric surgery and 12 months after bariatric surgery.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Nicolas CHEVALIER, Pr, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 24-PP-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No