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

NCT ID: NCT06597617

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2028-10-31

Brief 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. 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.

Conditions

Obesity; Bariatric Surgery Candidate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

GEA (Aerobic training)

Group Type: EXPERIMENTAL

Adapted physical activity with aerobic training [GEA]

Intervention Type: 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.

GRM (Strength training)

Group Type: EXPERIMENTAL

Adapted physical activity with strength training [GRM]

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas CHEVALIER, Pr

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

CHU de Nice

Nice, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nicolas CHEVALIER, Pr

Role: CONTACT

chevalier.n@chu-nice.fr

04 92 03 67 55 ext. +33

Facility Contacts

Nicolas CHEVALIER, Pr

Role: primary

chevalier.n@chu-nice.fr

04 92 03 67 55 ext. +33

Other Identifiers

24-PP-03

Identifier Type: -

Identifier Source: org_study_id