NCT06594588招募中不适用
Individualized Exploration of Aerobic Exercise-assisted Treatment of Depression Monitored by Smart Band: a Randomized Controlled Trial
Peking University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年9月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline in Hamilton Depression Rating Scale (HAMD)
研究概览
简要总结
The goal of this project is to quantify the relative effectiveness of aerobic exercise monitored by smart wristbands in assisting the treatment of depression and improving cognitive function. It aims to explore the mechanisms through which aerobic exercise exerts its effects using imaging genetics and other methods, and to identify suitable populations for exercise, ultimately providing personalized clinical exercise prescriptions. This study will intervene from a behavioral perspective and also seeks to motivate participants to change and improve their physical activity habits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-45 years (including 18 and 45), no gender restriction;
- •Meets the diagnostic criteria for depressive disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V);
- •Outpatients or inpatients; Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 14; Mood Disorder Questionnaire (MDQ) screening negative to exclude bipolar disorder patients; and Clinical Global Impressions-Severity (CGI-S) score ≥ 4;
- •Maintained on antidepressant treatment for at least 4 weeks or not using antidepressant treatment;
- •Written informed consent obtained from the patient.
排除标准
- •Diagnosed with other mental disorders, including schizophrenia, bipolar disorder, alcohol or substance abuse/dependence, eating disorders, etc.;
- •Individuals with intellectual disabilities or who are unable to cooperate for other reasons, or those lacking or having incomplete civil capacity during the onset of illness;
- •Suffering from neurological or organic brain diseases (such as stroke, cerebral hemorrhage, brain tumors, Parkinson's disease, epilepsy, etc.) and a history of severe traumatic brain injury;
- •Suffering from conditions with high exercise risk, such as hypertension or heart disease;
- •Currently undergoing systematic psychological therapy;
- •In the 3-minute step test, males with a recovery heart rate more than131 and females with a recovery heart rate more than 140;
- •Physically restricted individuals unable to participate in physical exercise;
- •Physical Activity Readiness Questionnaire (PAR-Q) score ≥ 2;
- •Pregnant women or individuals with contraindications to MRI examinations;
- •Individuals with severe suicidal tendencies or at risk of harming others.
结局指标
主要结局
Change from baseline in Hamilton Depression Rating Scale (HAMD)
时间窗: Week 4 and 8 of treatment duration
The outcome is assessed by HAMD-17 Scale.
次要结局
- Change from baseline in THINC-it score(Week 4 and 8 of treatment duration)
- Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)(Week 4 and 8 of treatment duration)
- Response to treatment(Week 4 and 8 of treatment duration)
- Clinical Global Impression-Severity of Illness (CGI-S)(Week 4 and 8 of treatment duration)
- Change from baseline in Hamilton Anxiety Rating Scale (HAMA)(Week 4 and 8 of treatment duration)
- Change from baseline in Ruminative Responses Scale (RRS)(Week 4 and 8 of treatment duration)
- Change from baseline in Pittsburgh Sleep Quality Index (PSQI)(Week 4 and 8 of treatment duration)
- Change from baseline in Connor-Davidson Resilience Scale (CD-RISC)(Week 4 and 8 of treatment duration)
- Rating Scale for Side Effects (SERS) -Antidepressant(Week 4 and 8 of treatment duration)
- Mood Disorder Questionnaire (MDQ)(Week 4 and 8 of treatment duration)
- International Physical Activity Questionnaire (IPAQ)(Week 4 and 8 of treatment duration)
- Biomarkers level(Week 0 and 8 of treatment duration)
- Body weight in kilograms(Week 4 and 8 of treatment duration)
- Body fat rate(Week 4 and 8 of treatment duration)
- Brain imaging features(Week 0 and 8 of treatment duration)
研究者
Weihua Yue
Professor
Peking University Sixth Hospital
研究点 (1)
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