UMIN-CTR Clinical Trial

Basic information
Public title	Aerobic exercise for cognitive impairment in schizophrenia: a pilot randomized controlled trial
Acronym	Aerobic exercise for cognitive impairment in schizophrenia: a pilot randomized controlled trial
Scientific Title	Aerobic exercise for cognitive impairment in schizophrenia: a pilot randomized controlled trial
Scientific Title:Acronym	Aerobic exercise for cognitive impairment in schizophrenia: a pilot randomized controlled trial
Region	Japan

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

Objectives
Narrative objectives1	To evaluate effects of aerobic exercises on cognition of schizophrenia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Brief Assessment of Cognition in Schizophrenia (BACS)
Key secondary outcomes	Schizophrenia Cognition Rating Scale (SCoRS) Quality of Life Scale (QLS) Life Assessment Scale for Mentally Ill (LASMI) Global Assessment of Functioning (GAF) Positive and Negative Syndrome Scale (PANSS) Scale for the Assessment of Negative Symptoms (SANS)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Exercise dosage was a 12-week, 2 sessions/week including 1 individual session (60-minute duration) and 1 group session (60-minute duration). The intensity of each session during the exercise sessions was individually calibrated at 60 to 80% of aerobic capacity.
Interventions/Control_2	treatment as usual
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	aged 20-65 years; inpatients in a psychiatric hospital; diagnosis of schizophrenia or schizoaffective disorder based on DSM-5
Key exclusion criteria	diagnosis of mental retardation or alcohol or drug disorders (abuse or dependence); any current or history of neurological disorders including head injury, cerebral vascular disorders, epilepsy, or dementia; and the difficulty for implementing aerobic exercise due to physical dysfunction
Target sample size	30

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	386-0401
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	386-0401
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	https://www.sciencedirect.com/science/article/abs/pii/S016517811931217X
Publication of results	Published

Result
URL related to results and publications	https://www.sciencedirect.com/science/article/abs/pii/S016517811931217X
Number of participants that the trial has enrolled	31
Results	This randomized trial demonstrated that integrating individual and group exercise training is feasible for use in a Japanese psychiatric hospital, and that it improves cognition and other outcomes of schizophrenia.
Results date posted	2022 Year 05 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Inclusion criteria: aged 20-65 years; inpatients in a psychiatric hospital; diagnosis of schizophrenia or schizoaffective disorder based on DSM-5 Exclusion criteria: diagnosis of mental retardation or alcohol or drug disorders (abuse or dependence); any current or history of neurological disorders including head injury, cerebral vascular disorders, epilepsy, or dementia; and the difficulty for implementing aerobic exercise due to physical dysfunction
Participant flow	Following the baseline assessment, eligible patients were randomized to treatment as usual (TAU) + aerobic exercise (AE) or TAU groups by independent study staff with whom there was no patient contact. Randomization was stratified by sex and age with the use of a computer-generated randomization program.
Adverse events	None
Outcome measures	Cognition Intrinsic motivation Social functioning Global functioning Psychopathology Negative symptoms
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 07 Day
Anticipated trial start date	2018 Year 11 Month 17 Day
Last follow-up date	2020 Year 05 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

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=R000039802