Discussion on the Intervention Effect of Shen-based Qigong Exercise on Residual Symptoms of Schizophrenia Based on the Theory of "Heart Dominating Mind" and "Body-spirit Syncretism" in Traditional Chinese Medicine
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change of the Scale for the Assessment of Negative Symptoms (SANS)
研究概览
简要总结
The purpose of this study is to observe the intervention effect of shen-based Qigong exercise on residual symptoms of schizophrenia.
详细描述
Shen-based Qigong exercise is a new kind of health-care Qigong exercise based on the theory of traditional Chinese medicine, aiming at the characteristics of schizophrenia. In this study, a randomized controlled trial was conducted to observe the rehabilitation effect of this new exercise on residual symptoms of schizophrenic patients. Questionnaire, test and other experimental materials were used to evaluate the intervention effect of 12-week shen-based Qigong exercise on psychiatric symptoms, cognitive function, quality of life and social function of schizophrenic patients. At the same time, the related physical function and cardiac function indexes were used to evaluate the physical and cardiac rehabilitation effects of the exercise on patients from the aspects of "body" and "heart", so as to verify whether Qigong exercise has the effects of adjusting body and heart.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Han Chinese population
- •age ≥ 18 years
- •education level ≥ 6 years, can fill in the questionnaire independently, have enough audio-visual level to complete the necessary examination
- •assessed by MINI 7.0 and satisfied with the diagnostic criteria for schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, fifth edition(DSM-5)
- •patients with schizophrenia residing in the rehabilitation ward, without relapse in the past 6 months
- •residual negative symptoms, with at least one item ≥ 2 on the negative subscale of PANSS (N1-N7)
- •taking second generation antipsychotics
- •no training history of traditional Chinese exercises
- •agreement to participate in the study and willing to give written informed consent
排除标准
- •having severe physical diseases such as cardiovascular, lung, liver, kidney, and hematopoietic diseases
- •satisfied with the diagnostic criteria for other mental disorders based on DSM-5
- •having alcohol or substance abuse/dependence
- •having mental retardation(WAIS<70) and/or severe cognitive impairment(MMSE<24)
- •having visual and / or hearing problems, unable to complete the relevant test
- •electroconvulsive or repetitive transcranial magnetic stimulation(rTMS) therapy in the past 3 months
- •currently enrolled or participated in other clinical studies in the past 3 months
- •participating in regular exercise training in the past 6 months
- •failure to sign or refuse to sign informed consent
结局指标
主要结局
change of the Scale for the Assessment of Negative Symptoms (SANS)
时间窗: Change from Baseline at 3 months
Negative symptoms will be evaluated using the Scale for the Assessment of Negative Symptoms (SANS). The scale made up for the lack of attention to negative symptoms in previous psychiatric rating scales. It contains five subscales: affective blunting, alogia, avolition/apathy, anhedonia/asociality, and attention. A total of 24 items were scored at 6 levels for each item.
次要结局
- change of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(Change from Baseline at 3 months)
- change of event-related potential P300 (ERP P300)(Change from Baseline at 3 months)