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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05310955
• Other study ID #: YSF2021-59
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2022
• Est. completion date: June 2023

Study information

• Verified date: August 2022
• Source: Shanghai Mental Health Center
• Contact: Anbei Lian
• Phone: 18117205070
• Email: 782115188[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Han Chinese population

2. age = 18 years

3. education level = 6 years, can fill in the questionnaire independently, have enough audio-visual level to complete the necessary examination

4. 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)

5. patients with schizophrenia residing in the rehabilitation ward, without relapse in the past 6 months

6. residual negative symptoms, with at least one item = 2 on the negative subscale of PANSS (N1-N7)

7. taking second generation antipsychotics

8. no training history of traditional Chinese exercises

9. agreement to participate in the study and willing to give written informed consent

Exclusion Criteria:

1. having severe physical diseases such as cardiovascular, lung, liver, kidney, and hematopoietic diseases

2. satisfied with the diagnostic criteria for other mental disorders based on DSM-5

3. having alcohol or substance abuse/dependence

4. having mental retardation(WAIS<70) and/or severe cognitive impairment(MMSE<24)

5. having visual and / or hearing problems, unable to complete the relevant test

6. electroconvulsive or repetitive transcranial magnetic stimulation(rTMS) therapy in the past 3 months

7. currently enrolled or participated in other clinical studies in the past 3 months

8. participating in regular exercise training in the past 6 months

9. failure to sign or refuse to sign informed consent

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• daily rehabilitation interventions
including Naikan therapy, Morita therapy, group art therapy, group painting therapy
• shen-based Qigong exercise
a 12-week intervention of shen-based Qigong exercise : exercise 5 days a week, about 30 minutes a day

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	change of 36-item Short Form Health Survey(SF-36)	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
Other	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
Other	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
Other	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
Other	change of height	Height will be measured using a height ruler, expressed in meters.	Change from Baseline at 3 months
Other	change of weight	Weight will be measured using a weighting scale, expressed in kilograms.	Change from Baseline at 3 months
Other	change of waistline	Waistline will be measured using a flexible rule, expressed in centimeters.	Change from Baseline at 3 months
Other	change of blood pressure	Blood pressure will be measured using a sphygmomanometer, expressed in millimeter of mercury.	Change from Baseline at 3 months
Other	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
Primary	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	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
Secondary	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