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

Not Applicable

• Conditions: Schizophrenia
• Interventions: Other: daily rehabilitation interventions; Other: shen-based Qigong exercise

• Registration Number: NCT05310955
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-02-22
• Study First Submitted QC: 2022-03-26
• Study First Posted: 2022-04-05
• Status Verified: 2022-08
• Study Start: 2022-08-16
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	shen-based Qigong exercise	daily rehabilitation interventions and shen-based Qigong exercise
Interventional group	daily rehabilitation interventions	daily rehabilitation interventions and shen-based Qigong exercise
Control group	daily rehabilitation interventions	daily rehabilitation interventions

Primary Outcome Measures

Name	Time	Method
change of the Scale for the Assessment of Negative Symptoms (SANS)	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.

Secondary Outcome Measures

Name	Time	Method
change of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	Change from Baseline at 3 months	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 of event-related potential P300 (ERP P300)	Change from Baseline at 3 months	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.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China