Tokyo, July 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062151) titled 'Standardized exercise intervention for patients with schizophrenia: Feasibility and preliminary cognitive outcomes of a pilot randomized controlled trial' on July 6.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Other
Condition:
Condition - Schizophrenia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To test feasibility, safety, adherence, and preliminary cognitive outcomes of a standardized yet flexible exercise program in patients with schizophrenia.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Exercise intervention
Interventions/Control_2 - Treatment as usual
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) age 18-60 years
(2) a diagnosis of schizophrenia confirmed by the Structured Clinical Interview for DSM-5 Disorders Research Version
Key exclusion criteria - (1) a current primary DSM-5 diagnosis other than schizophrenia
(2) history of mental retardation
(3) history of neurological disorder
(4) significant drug or alcohol abuse within 6 months prior to consent
(5) psychosis secondary to substance abuse
(6) current risk of suicide or a history of suicidal behavior within 6 months prior to consent
(7) the presence of comorbid serious physical disorder
Target Size - 40
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 10 Month 01 Day
Date of IRB - 2025 Year 10 Month 01 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2026 Year 10 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071126
Disclaimer: Curated by HT Syndication.
