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RecruitingNCT06597617

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Centre Hospitalier Universitaire de Nice · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALAdapted 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.
BEHAVIORALAdapted 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.

Timeline

Start date
2025-06-01
Primary completion
2028-06-01
Completion
2028-10-01
First posted
2024-09-19
Last updated
2025-03-25

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06597617. Inclusion in this directory is not an endorsement.