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| Name | Class |
|---|---|
| Shanghai University of Traditional Chinese Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Experimental | daily rehabilitation interventions |
|
| Interventional group | Experimental | daily rehabilitation interventions and shen-based Qigong exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| daily rehabilitation interventions | Other | including Naikan therapy, Morita therapy, group art therapy, group painting therapy |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change of n-back task | Specific cognitive domain--working memory will be assessed by n-back task. N-back task paradigm is the most classical paradigm in working memory research. | Change from Baseline at 3 months |
| change of 36-item Short Form Health Survey（SF-36） |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anbei Lian | Contact | 18117205070 | 782115188@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Qing Fan | Shanghai Mental Health Center | Study Chair |
| Xiaodan Liu | School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39538216 | Derived | Shen H, Lian A, Wu Y, Zhou J, Liu Y, Zhu L, Zhang Y, Yi Z, Liu X, Fan Q. Shen-based Qigong Exercise improves cognitive impairment in stable schizophrenia patients in rehabilitation wards: a randomized controlled study. BMC Psychiatry. 2024 Nov 13;24(1):796. doi: 10.1186/s12888-024-06146-8. | |
| 37842323 | Derived |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| shen-based Qigong exercise | Other | a 12-week intervention of shen-based Qigong exercise : exercise 5 days a week, about 30 minutes a day |
|
| 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 |
36-item Short Form Health Survey（SF-36）will be used to assess the health-related quality of life of patients. SF-36 is one of the most commonly used standardized measurement tools for quality of life in the world, including eight subscales, a total of 36 items, involving physical and mental health. |
| Change from Baseline at 3 months |
| change of Social-Adaptive Functioning Evaluation (SAFE) | Social functions will be assessed using Social-Adaptive Functioning Evaluation (SAFE). SAFE can evaluate the social adaptation function of patients with mental disorders over 18 years old. It has a total of 19 items, divided into basic life skills, advanced life skills, social skills and communication skills in four areas; each item 0-4 score, the higher the score, the more serious the damage. | Change from Baseline at 3 months |
| change of the Scale for the Assessment of Positive Symptoms (SAPS) | Positive symptoms will be evaluated using the Scale for the Assessment of Positive Symptoms (SAPS). SAPS measures positive symptoms on a 34 item, 6-point scale, a total of 170 points. Items are listed under hallucinations, delusions, bizarre behavior, and positive formal thought disorder. | Change from Baseline at 3 months |
| change of heart rate variability (HRV) | Heart rate variability (HRV) will be used as the evaluation index for cardiac function. HRV is a widely used non-invasive tool for evaluating cardiac autonomic nerve function. | Change from Baseline at 3 months |
| change of height | Height will be measured using a height ruler, expressed in meters. | Change from Baseline at 3 months |
| change of weight | Weight will be measured using a weighting scale, expressed in kilograms. | Change from Baseline at 3 months |
| change of waistline | Waistline will be measured using a flexible rule, expressed in centimeters. | Change from Baseline at 3 months |
| change of blood pressure | Blood pressure will be measured using a sphygmomanometer, expressed in millimeter of mercury. | Change from Baseline at 3 months |
| change of gait data | Acquire gait data in a quiet, well-lit room. Specify the walking area to guide the participants to complete the walking cycle. | Change from Baseline at 3 months |
| Lian A, Fan Q, Wang W, Liu Q, Shi J, Zhuang M, Li Y, Liu X. Effect of 12-week shen-based qigong exercise on the residual symptoms of schizophrenia: Study protocol for a single-centre randomised controlled trial. Contemp Clin Trials Commun. 2023 Oct 3;36:101214. doi: 10.1016/j.conctc.2023.101214. eCollection 2023 Dec. |