Intervention Effect of Shen-based Qigong Exercise on Residual Symptoms of Schizophrenia

Study Overview
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Brief Summary
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The purpose of this study is to observe the intervention effect of shen-based Qigong exercise on residual symptoms of schizophrenia.

Detailed Description
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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.

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: daily rehabilitation interventions
* Other: shen-based Qigong exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group<br>daily rehabilitation interventions | Other: daily rehabilitation interventions<br>* including Naikan therapy, Morita therapy, group art therapy, group painting therapy<br>|
| Experimental: Interventional group<br>daily rehabilitation interventions and shen-based Qigong exercise | Other: daily rehabilitation interventions<br>* including Naikan therapy, Morita therapy, group art therapy, group painting therapy<br>Other: shen-based Qigong exercise<br>* a 12-week intervention of shen-based Qigong exercise : exercise 5 days a week, about 30 minutes a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of the Scale for the Assessment of Negative Symptoms (SANS) | 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. | Change from Baseline at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | RBANS will be used to assess global cognitive function. RBANS yields scaled scores for 5 cognitive domains and shows a good effect in cognitive assessment of patients with schizophrenia. | Change from Baseline at 3 months | 
| change of event-related potential P300 (ERP P300) | ERP P300 will be used to assess global cognitive function. ERP P300 is an endogenous cognitive component related to high-level psychological activities such as attention, memory, feeling, learning and reasoning. It has good stability and can reflect the level of cognitive function from different aspects. | Change from Baseline at 3 months |