Baduanjin combined with computerized cognitive remediation therapy for the treatment of schizophrenia : a 8-week randomized controlled trial

ISRCTN	ISRCTN14037337
DOI	https://doi.org/10.1186/ISRCTN14037337
Sponsor	The Second People's Hospital of Chuzhou (also the Municipal Infectious Disease Hospital and the Municipal Psychiatric Hospital of Chuzhou)
Funder	Anhui Provincial Department of Education

Submission date: 14/03/2026
Registration date: 12/05/2026
Last edited: 12/05/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Wei Liang
Public, Scientific, Principal investigator

No. 1401 Qingliu Middle Road
Chuzhou
239000
China

ORCID ID	0009-0008-3454-5718
Phone	+86 18943586240
Email	liangweiw@qq.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Crossover
Purpose	Treatment
Scientific title	Baduanjin combined with computerized cognitive remediation therapy for the treatment of schizophrenia : a 8-week randomized controlled trial
Study objectives
Ethics approval(s)	Approved 14/10/2024, Medical Ethics Committee of Chuzhou Second People's Hospital (No. 1401 Qingliu Middle Road, Chuzhou, 239000, China; +86 5503523299; 2895710891@qq.com), ref: No. 2024-Yuan-Lun-Shen-Yi-Zi-No. (06)
Health condition(s) or problem(s) studied	Schizophrenia
Intervention	Participants in the intervention group received a combined 85-minute session (45 minutes of CCRT plus 40 minutes of Baduanjin training) five times per week, whereas the control group received CCRT alone for the same duration. Assessments of psychiatric symptoms, cognitive function, social functioning, and quality of life were conducted at baseline and post-intervention. Total duration of treatment and follow-up: The intervention period for both study arms (the combined intervention group and the control group) was 8 weeks. All assessments were conducted at two time points: baseline (pre-intervention) and immediately post-intervention (at the end of the 8-week treatment period). No extended follow-up assessment (e.g., at 3 or 6 months) was conducted for this study, which we have now acknowledged as a limitation. Randomisation process: Sequence generation: Eligible participants were sequentially numbered based on the first letter of their names and randomly assigned to either the combined intervention group or the control group in a 1:1 ratio using a computer-generated random number table (generated using SPSS version 26.0). Allocation concealment: Allocation concealment was ensured by using sequentially numbered, opaque, sealed envelopes. These envelopes were prepared by an independent researcher who was not involved in participant recruitment or outcome assessment. Implementation: An independent research assistant generated the random allocation sequence. A separate team member, who was not involved in outcome assessment, enrolled participants and assigned them to interventions by opening the sealed envelopes in numerical order. Envelopes were opened only after participants completed baseline assessments and provided written informed consent.
Intervention type	Behavioural
Primary outcome measure(s)	Quality of life measured using the Schizophrenia Quality of Life Scale at after intervention
Key secondary outcome measure(s)
Completion date	28/03/2026

Eligibility

Participant type(s)
Age group	All
Lower age limit	0 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	200
Total final enrolment	120
Key inclusion criteria	1. Diagnosed with schizophrenia by a clinician according to the diagnostic criteria for schizophrenia in the WHO International Classification of Diseases, 10th Revision (ICD-10) 2. Hospitalized for ≥1 year 3. Maintained stable medication dosage for ≥3 months
Key exclusion criteria	1. Individuals with severe physical conditions, such as serious cardiovascular, pulmonary, or musculoskeletal disorders, that prevent participation in exercise 2. Visual and/or hearing impairments that prevent completion of neurocognitive testing 3. Coexisting mental or neurological disorders
Date of first enrolment	01/06/2024
Date of final enrolment	14/03/2026

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other files	Consent form in Chinese		16/03/2026	No	No

Additional files

49204 consent form.pdf: Consent form in Chinese

Editorial Notes

16/03/2026: Trial's existence confirmed by Medical Ethics Committee of Chuzhou Second People's Hospital.