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临床试验/NCT04631952
NCT04631952Unknown不适用

A Randomised Controlled Trial of Online Exercise Intervention for Psychosis Patients Receiving Residential Care in Hong Kong

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
180
试验地点
1
主要终点
Exercise level

研究概览

简要总结

The main objective of this randomised controlled trial (RCT) is to investigate the immediate and long-term effectiveness of 8-week online exercise intervention for people with psychosis receiving residential care.

详细描述

The effect will also be evaluated after 6-month and 12-month, anticipate seeing the maintenance of physical activity throughout a year of time.

The secondary objective of this RCT is to investigate if the exercise intervention will be effective in improving the clinical symptoms, cognitive functioning and social functioning of the subjects, and to see if the improvement can be maintained (or improve) over a longer period of time (i.e., 6-month and 12-month).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Based on the Fifth version of the Diagnostic and Statistical Manual of Mental Disorders diagnosis to have schizophrenia and related psychotic disorders
  • Have the ability to understand Chinese
  • Able to give informed consent

排除标准

  • Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders.
  • Comorbid substance dependence
  • Unstable psychotic symptoms
  • Any history of brain trauma or organic brain disease
  • Known history of intellectual disability or special school attendance
  • Other mental conditions that requires other treatment priorities, e.g., suicidal risk.
  • Other medical conditions that severely limits participation, comprehension, or adherence to the treatment or assessment e.g., epilepsy, dementia, terminal medical illness.

结局指标

主要结局

Exercise level

时间窗: 6 months and 12 months

Measured by the International Physical Activity Questionnaire, a higher MET calculated from the scale indicates a higher exercise level

次要结局

  • Severity of psychotic symptoms(6 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Yi-Nam Suen

Research Assistant Professor

The University of Hong Kong

研究点 (1)

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