Clinical trial NCT05310955: Intervention Effect of Shen-based Qigong Exercise on Residual Symptoms of Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Shanghai University of Traditional Chinese Medicine
First posted: 2022-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: change of the Scale for the Assessment of Negative Symptoms (SANS)
timeFrame: Change from Baseline at 3 months
Secondary outcomes:
measure: change of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Change from Baseline at 3 months
measure: change of event-related potential P300 (ERP P300)
timeFrame: Change from Baseline at 3 months
Other outcomes:
measure: change of n-back task
timeFrame: Change from Baseline at 3 months
measure: change of 36-item Short Form Health Survey（SF-36）
timeFrame: Change from Baseline at 3 months
measure: change of Social-Adaptive Functioning Evaluation (SAFE)
timeFrame: Change from Baseline at 3 months
measure: change of the Scale for the Assessment of Positive Symptoms (SAPS)
timeFrame: Change from Baseline at 3 months
measure: change of heart rate variability (HRV)
timeFrame: Change from Baseline at 3 months
measure: change of height
timeFrame: Change from Baseline at 3 months
measure: change of weight
timeFrame: Change from Baseline at 3 months
measure: change of waistline
timeFrame: Change from Baseline at 3 months
measure: change of blood pressure
timeFrame: Change from Baseline at 3 months
measure: change of gait data
timeFrame: Change from Baseline at 3 months
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Qing Fan
role: STUDY_CHAIR
affiliation: School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine
name: Xiaodan Liu
role: STUDY_CHAIR
References: