A Randomised Controlled Trial of Aerobic Exercise for Adolescents With Subthreshold Depressive and/or Hypomanic Syndrome and for Non-clinical Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Changes in neurocognitive function
研究概览
简要总结
This study will investigate the effects of aerobic exercise on mental states, cognition, and long-term outcomes in adolescents with subthreshold depressive and/or hypomanic syndromes and in non-clinical school children
详细描述
Subthreshold depressive and hypomanic symptoms are common in adolescents, increasing the risk of developping into depression or bipolar disorder. Preliminary evidence shows that aerobic exercise might have positive effects in enhancing cognition and improving clinical symptoms in non-clinical and preclinical population and patients with mood disorders. This randomized controlled trial will investigate short-term (3 months) effects of aerobic exercise on cognition and clinical symptoms as well as the long-term (18 months) effects on the clinical outcomes of high-risk states.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2 or more DSM-IV defined depressive symptoms, with one as core symptoms ( lost interest or pleasure in activity or depressed mood), lasting for 1 week.
- •2 or more DSM-IV defined manic symptoms, last for 4 days, but falling short of the criteria for hypomania; or meeting DSM-5 defined symptoms criteria for hypomania, lasting 2-3 days.
- •non-clinical subjects
排除标准
- •DSM-IV defined major depressive disorder
- •DSM-IV defined hypo/mania
- •History of or current other Axis I Disorders
- •Diagnosed neurological or musculoskeletal disorder/injury,
- •Uncontrolled cardiovascular or metabolic diseases that are not suitable for running
- •Diagnosed hypertension
- •Other diagnosed serious medical conditions that are not suitable for cycling
- •Severe suicidal ideation
- •Mental retardation
- •Currently participating in a exercise program or activity, defined as 30 minutes of vigorous physical activity 4-5 times per week
研究组 & 干预措施
aerobic exercise
Running at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 3 months
干预措施: aerobic exercise (Behavioral)
Placebo controlled group
6 sections of group activities: 3 sections of general psychological education; one section of group game, one section of group poetry reading activity, group singing entertainment.
干预措施: Placebo controlled group (Behavioral)
结局指标
主要结局
Changes in neurocognitive function
时间窗: 12 weeks
Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise
Changes in depressive symptoms
时间窗: 12 weeks
Changes in depressive symptoms measured by Patient Health Questionnaire (PHQ-9)
次要结局
- Changes in hypomanic symptoms(12 weeks)
- Changes in brain connectivity(12 weeks)
- changes in anxious symptoms(12 weeks)
- Number of participants with subthreshold mood symptoms(18 months)
研究者
Kangguang Lin
MD, PhD
Guangzhou Psychiatric Hospital