UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034910 |
|---|---|
| Receipt number | 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 | 2022/05/16 16:01:47 |
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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 | 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
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
ot@seitaikai.or.jp
Sponsor or person
Institute
Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039802
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