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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034910
Receipt No. R000039802
Scientific Title Aerobic exercise for cognitive impairment in schizophrenia: a pilot randomized controlled trial
Date of disclosure of the study information 2018/11/17
Last modified on 2018/11/16

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

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Shimada
Organization Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Division name Department of Rehabilitation
Zip code
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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 17 Day
Last follow-up date
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
2018 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039802

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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