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

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
daily rehabilitation interventions
shen-based Qigong exercise
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control group

Interventional group

Arm Description

daily rehabilitation interventions

daily rehabilitation interventions and shen-based Qigong exercise

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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.

Full Information

First Posted
February 22, 2022
Last Updated
October 25, 2022
Sponsor
Shanghai Mental Health Center
Collaborators
Shanghai University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05310955
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Shanghai University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
daily rehabilitation interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
daily rehabilitation interventions and shen-based Qigong exercise
Intervention Type
Other
Intervention Name(s)
daily rehabilitation interventions
Intervention Description
including Naikan therapy, Morita therapy, group art therapy, group painting therapy
Intervention Type
Other
Intervention Name(s)
shen-based Qigong exercise
Intervention Description
a 12-week intervention of shen-based Qigong exercise : exercise 5 days a week, about 30 minutes a day
Primary Outcome Measure Information:
Title
change of the Scale for the Assessment of Negative Symptoms (SANS)
Description
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.
Time Frame
Change from Baseline at 3 months
Secondary Outcome Measure Information:
Title
change of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Description
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.
Time Frame
Change from Baseline at 3 months
Title
change of event-related potential P300 (ERP P300)
Description
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.
Time Frame
Change from Baseline at 3 months
Other Pre-specified Outcome Measures:
Title
change of n-back task
Description
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.
Time Frame
Change from Baseline at 3 months
Title
change of 36-item Short Form Health Survey（SF-36）
Description
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.
Time Frame
Change from Baseline at 3 months
Title
change of Social-Adaptive Functioning Evaluation (SAFE)
Description
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.
Time Frame
Change from Baseline at 3 months
Title
change of the Scale for the Assessment of Positive Symptoms (SAPS)
Description
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.
Time Frame
Change from Baseline at 3 months
Title
change of heart rate variability (HRV)
Description
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.
Time Frame
Change from Baseline at 3 months
Title
change of height
Description
Height will be measured using a height ruler, expressed in meters.
Time Frame
Change from Baseline at 3 months
Title
change of weight
Description
Weight will be measured using a weighting scale, expressed in kilograms.
Time Frame
Change from Baseline at 3 months
Title
change of waistline
Description
Waistline will be measured using a flexible rule, expressed in centimeters.
Time Frame
Change from Baseline at 3 months
Title
change of blood pressure
Description
Blood pressure will be measured using a sphygmomanometer, expressed in millimeter of mercury.
Time Frame
Change from Baseline at 3 months
Title
change of gait data
Description
Acquire gait data in a quiet, well-lit room. Specify the walking area to guide the participants to complete the walking cycle.
Time Frame
Change from Baseline at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Han Chinese population age ≥ 18 years education level ≥ 6 years, can fill in the questionnaire independently, have enough audio-visual level to complete the necessary examination 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) patients with schizophrenia residing in the rehabilitation ward, without relapse in the past 6 months residual negative symptoms, with at least one item ≥ 2 on the negative subscale of PANSS (N1-N7) taking second generation antipsychotics no training history of traditional Chinese exercises agreement to participate in the study and willing to give written informed consent Exclusion Criteria: having severe physical diseases such as cardiovascular, lung, liver, kidney, and hematopoietic diseases satisfied with the diagnostic criteria for other mental disorders based on DSM-5 having alcohol or substance abuse/dependence having mental retardation(WAIS<70) and/or severe cognitive impairment(MMSE<24) having visual and / or hearing problems, unable to complete the relevant test electroconvulsive or repetitive transcranial magnetic stimulation(rTMS) therapy in the past 3 months currently enrolled or participated in other clinical studies in the past 3 months participating in regular exercise training in the past 6 months failure to sign or refuse to sign informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anbei Lian
Phone
18117205070
Email
782115188@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qing Fan
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xiaodan Liu
Organizational Affiliation
School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anbei Lian
Phone
18117205070
Email
782115188@qq.com

12. IPD Sharing Statement

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

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