UMIN-CTR Clinical Trial

Basic information
Public title	Aerobic exercise for cognitive impairment in schizophrenia: A systematic review and meta-analysis
Acronym	Aerobic exercise for cognitive impairment in schizophrenia: A systematic review and meta-analysis
Scientific Title	Aerobic exercise for cognitive impairment in schizophrenia: A systematic review and meta-analysis
Scientific Title:Acronym	Aerobic exercise for cognitive impairment in schizophrenia: A systematic review and meta-analysis
Region	Japan

Condition
Condition	schizophrenia
Classification by specialty	Psychiatry Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of (aerobic exercise, AE) on cognition of schizophrenia and to examine the methods of AE for enhancing cognitive functioning
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cognitive functioning
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	controlled trials that evaluated the effects of aerobic exercise on cognition of schizophrenia
Key exclusion criteria	studies not met inclusion criteria
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Shimada
Organization	Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Division name	Department of Rehabilitation
Zip code	3860401
Address	3057-1, Shiogawa, Ueda, Nagano, Japan
TEL	0268-35-0305
Email	ot@seitaikai.or.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Shimada
Organization	Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Division name	Department of Rehabilitation
Zip code	3860401
Address	3057-1, Shiogawa, Ueda, Nagano, Japan
TEL	0268-35-0305
Homepage URL
Email	ot@seitaikai.or.jp

Sponsor
Institute	Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Address	3057-1, Shiogawa, Ueda, Nagano, Japan
Tel	0268-35-0305
Email	ot@seitaikai.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	593
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 11 Month 07 Day
Date of IRB	2018 Year 11 Month 17 Day
Anticipated trial start date	2018 Year 11 Month 17 Day
Last follow-up date	2022 Year 05 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Two independent authors conducted an electronic database search of Ovid MEDLINE, Cochrane Central Register of Controlled Trials, Health Technology Assessment Database, PsycINFO, Web of Science from inception to November 2018. The search terms used were: ("schizophrenia spectrum and other psychotic disorders"[Mesh]) and ("exercise"[Mesh] or "physical fitness"[Mesh] or "resistance training"[Mesh]) and ("cognition"[Mesh] or "cognitive science"[Mesh]). The reference lists of retrieved articles were also searched.

Management information
Registered date	2018 Year 11 Month 16 Day
Last modified on	2022 Year 05 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039801