Neurological Impact of Weight Reduction and Fitness Interventions (NCT06830252) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Neurological Impact of Weight Reduction and Fitness Interventions
Australia50 participantsStarted 2025-02
Plain-language summary
This study will test how significant weight loss through bariatric surgery, combined with a personalised exercise program, affects brain inflammation. Th investigators want to understand the connection between obesity-related body inflammation, metabolic issues, and brain inflammation and function.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 18-80 years of age.
* Eligible for bariatric surgery.
* Willingness to provide informed consent and willingness to participate and comply with the study requirements
Exclusion Criteria:
* Unable to undertake MRI due to size restrictions i.e., shoulder width more than 70 cm.
* History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardio- vascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic, muscular, and joint disorders, or cancer that, in the opinion of the investigator, would make the candidate ineligible for the study. For example, significant joint pain could interfere with adherence to the exercise program.
* Have objectively assessed cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA) i.e., total score less than 26.
* Non-MRI-compatible implanted devices or implants.
* Inability to exercise via supine ergometer.
* Claustrophobia.
* Psychiatric or behavioural problems (history of drug and alcohol abuse, eating disorder).
* Breastfeeding or pregnant women, or those intending to become pregnant before the scheduled end of the intervention.
* Unwilling to be assigned at random to the exercise or control intervention.
* Unwilling or unable to adhere to the rigors of the exercise intervention or evaluation schedule over the entire one-year period.
* Concurrent participation in any other interventional study.