Intervention study on the combined effect of cognitive remediation therapy and exercise therapy for schizophrenia patients

Not Applicable

• Conditions: Schizophrenia

• Registration Number: JPRN-UMIN000050885
• Lead Sponsor: Department of Psychiatry, Tohoku University Hospital Department of Psychiatry, Graduate School of Medicine, Tohoku University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-19
• Last Update Posted: 17 October 2023
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Those who have a medical history or undergoing treatment at the time of first registration as follows; substance dependence, head injury, lifestyle-related diseases (hypertension, hyperlipidemia, diabetes), or vascular disorders (brain, cardiac, etc.), eye disease (cataract, glaucoma, etc.) or severe visual impairment (myopia, hyperopia, etc.), diagnosis of dementia, or those who score 21 points or less on the cognitive function evaluation MMSE (Mini-Mental State Examination). (2) Subjects whose exercise is restricted by a doctor for some reason (orthopedic or medical reasons) at the time of first registration. (3)Patients judged by the attending psychiatrist to be significantly lacking in consent due to marked hallucinations/delusions or thought disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(1) Evaluation of neurocognitive/social cognition function: The Brief Assessment of Cognition in Schizophrenia Japanese version (BACS.J), Social Cognition Screening Questionnaire Japanese version (SCSQ.J) (2) Psychiatric symptoms assessment: Global Assessment of Functioning (GAF), Positive and Negative Syndrome Scale (PANSS) (3) Evaluation of quality of life (QOL): Schizophrenia Quality of Life Scale Japanese version (SQLS.J) (4) Retinal layers: Measure the retinal nerve fiber layer (RNFL), ganglion cell layer complex (GCC), macular volume, macular thickness, etc by SD-OCT. Implemented only at Tohoku University Hospital. (5) Evaluation of Body composition: body fat percentage, muscle mass, basal metabolic rate, etc. (measured by body composition meter)

Secondary Outcome Measures

Name	Time	Method
1) Evaluation of self-stigma: The Internalized Stigma of Illness Scale, Japanese version (ISMI.J) 2) Evaluation of personality tendency: Ten Item Personality Inventory Japanese versions (TIPI.J), The Autism-Spectrum Quotient Japanese versions (AQ.J)