SchizophreniaNCT05310955
Intervention Effect of Shen-based Qigong Exercise on Residual Symptoms of Schizophrenia
A study testing daily rehabilitation interventions and shen-based Qigong exercise in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The purpose of this study is to observe the intervention effect of shen-based Qigong exercise on residual symptoms of schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- daily rehabilitation interventions and shen-based Qigong exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- taking second generation antipsychotics
- no training history of traditional Chinese exercises
- agreement to participate in the study and willing to give written informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Anbei Lian, 18117205070, 782115188@qq.com
About this study
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
The purpose of this study is to observe the intervention effect of shen-based Qigong exercise on residual symptoms of schizophrenia.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- daily rehabilitation interventions, shen-based Qigong exercise
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daily rehabilitation interventionsOther
including Naikan therapy, Morita therapy, group art therapy, group painting therapy
shen-based Qigong exerciseOther
a 12-week intervention of shen-based Qigong exercise : exercise 5 days a week, about 30 minutes a day
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | daily rehabilitation interventions Receives: Other: daily rehabilitation interventions |
| Interventional group | Experimental | daily rehabilitation interventions and shen-based Qigong exercise Receives: Other: daily rehabilitation interventions; Other: shen-based Qigong exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline at 3 months
Secondary outcomes (2)
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.
Measured: Change from Baseline at 3 months
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.
Measured: Change from Baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start16 Aug 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Qing Fan, Study chair, Shanghai Mental Health CenterXiaodan Liu, Study chair, School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310955
- Sponsor's protocol ID
- YSF2021-59
- Status last verified
- Aug 2022
- First submitted
- 22 Feb 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39538216Lian 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.
PubMed 37842323
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05310955
- Acronym / sponsor ID
- YSF2021-59
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Other: daily rehabilitation interventionsdaily rehabilitation interventions |
| Interventional group | Experimental | Other: daily rehabilitation interventions, Other: shen-based Qigong exercisedaily rehabilitation interventions and shen-based Qigong exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| daily rehabilitation interventionsincluding Naikan therapy, Morita therapy, group art therapy, group painting therapy | Other | Control group, Interventional group |
| shen-based Qigong exercisea 12-week intervention of shen-based Qigong exercise : exercise 5 days a week, about 30 minutes a day | Other | Interventional group |
Primary outcome
change of the Scale for the Assessment of Negative Symptoms (SANS)
Time frame: 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.
2 secondary outcomes
change of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: Change from Baseline at 3 months
change of event-related potential P300 (ERP P300)
Time frame: Change from Baseline at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 39538216Shen 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.
- Derived from this study: PubMed 37842323Lian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Fan study chair
Shanghai Mental Health Center
Xiaodan Liu study chair
School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing daily rehabilitation interventions and shen-based Qigong exercise in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anbei Lian (18117205070, 782115188@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of the Scale for the Assessment of Negative Symptoms (SANS) (time frame: Change from Baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05310955, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.