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

S

Shanghai Mental Health Center

Status

Enrolling

Conditions

Schizophrenia

Treatments

Other: daily rehabilitation interventions
Other: shen-based Qigong exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT05310955
YSF2021-59

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Control group
Experimental group
Description:
daily rehabilitation interventions
Treatment:
Other: daily rehabilitation interventions
Interventional group
Experimental group
Description:
daily rehabilitation interventions and shen-based Qigong exercise
Treatment:
Other: daily rehabilitation interventions
Other: shen-based Qigong exercise

Trial contacts and locations

1

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Central trial contact

Anbei Lian

Data sourced from clinicaltrials.gov

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