ACTRN12624001065583尚未招募Unknown
A randomised controlled trial to evaluate the effects of marked weight loss combined with exercise training on metabolic, immunological, and imaging biomarkers of systemic and brain inflammation in participants undergoing bariatric surgery.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years(—)
- 性别
- All
入选标准
- •18-80 years of age.
- •-Eligible for bariatric surgery.
- •-Willingness to provide informed consent and willingness to participate and comply with the study requirements
排除标准
- •-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.
研究者
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