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

NCT ID: NCT05310955

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-16

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

daily rehabilitation interventions

Group Type EXPERIMENTAL

daily rehabilitation interventions

Intervention Type OTHER

including Naikan therapy, Morita therapy, group art therapy, group painting therapy

Interventional group

daily rehabilitation interventions and shen-based Qigong exercise

Group Type EXPERIMENTAL

daily rehabilitation interventions

Intervention Type OTHER

including Naikan therapy, Morita therapy, group art therapy, group painting therapy

shen-based Qigong exercise

Intervention Type OTHER

a 12-week intervention of shen-based Qigong exercise : exercise 5 days a week, about 30 minutes a day

Interventions

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daily rehabilitation interventions

including Naikan therapy, Morita therapy, group art therapy, group painting therapy

Intervention Type OTHER

shen-based Qigong exercise

a 12-week intervention of shen-based Qigong exercise : exercise 5 days a week, about 30 minutes a day

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qing Fan

Role: STUDY_CHAIR

Shanghai Mental Health Center

Xiaodan Liu

Role: STUDY_CHAIR

School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine

Locations

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Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Anbei Lian

Role: CONTACT

18117205070

Facility Contacts

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Anbei Lian

Role: primary

18117205070

References

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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.

Reference Type DERIVED
PMID: 39538216 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37842323 (View on PubMed)

Other Identifiers

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YSF2021-59

Identifier Type: -

Identifier Source: org_study_id

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