UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042448 |
|---|---|
| Receipt number | R000048456 |
| Scientific Title | Exercise dose and cognition in schizophrenia: a randomized controlled trial |
| Date of disclosure of the study information | 2020/11/13 |
| Last modified on | 2022/05/16 16:26:58 |
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Basic information
Public title
Exercise dose and cognition in schizophrenia: a randomized controlled trial
Acronym
Exercise dose and cognition in schizophrenia: a randomized controlled trial
Scientific Title
Exercise dose and cognition in schizophrenia: a randomized controlled trial
Scientific Title:Acronym
Exercise dose and cognition in schizophrenia: a 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 test the dose response effect of an aerobic exercise training on cognition, motivation, psychiatric symptom, and functioning in patients with schizophrenia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognition
Key secondary outcomes
Intrinsic motivation
Psychiatric symptom
Functioning
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
4
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
non-exercise control
Interventions/Control_2
2 times/week, 12 weeks exercise dose
Interventions/Control_3
3 times/week, 12 weeks exercise dose
Interventions/Control_4
2 times/week, 24 weeks exercise dose
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) diagnosed with schizophrenia based on the the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Key exclusion criteria
(1) a current primary DSM-5 diagnosis other than schizophrenia
(2) a history of mental retardation
(3) a history of neurological disorder
(4) a history of significant drug or alcohol abuse
(5) current risk of suicide, or a history of suicidal behavior within 6 months prior to consent
(6) comorbid serious physical disorder
Target sample size
60
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
医療法人清泰会メンタルサポートそよかぜ病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S0920996421002681
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S0920996421002681
Number of participants that the trial has enrolled
41
Results
This study aimed to detect a dose-response gradient but could not distinguish which exercise dose provided greater cognitive benefits. Therefore, if the exercise dose lasts at least 60 min per session, two sessions per week for 12 weeks, the effect of aerobic exercise on cognition can possibly be generalized to patients with 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
Key inclusion criteria
(1) diagnosed with schizophrenia based on the the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Key exclusion criteria
(1) a current primary DSM-5 diagnosis other than schizophrenia
(2) a history of mental retardation
(3) a history of neurological disorder
(4) a history of significant drug or alcohol abuse
(5) current risk of suicide, or a history of suicidal behavior within 6 months prior to consent
(6) comorbid serious physical disorder
Participant flow
This was a 4-arm randomized controlled trial to evaluate the dose-response effect of aerobic exercise on cognition in patients with schizophrenia. Among the randomized 41 patients with schizophrenia, 40 patients included in the intent-to-treat population were randomized to non-exercise placebo control (n = 10); 2 times/week, 12 weeks exercise dose (n = 10); 3 times/week, 12 weeks exercise dose (n = 10); and 2 times/week, 24 weeks exercise dose (n = 10) groups.
Adverse events
None
Outcome measures
Cognition
Intrinsic motivation
Psychiatric symptom
Functioning
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 13 | 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=R000048456
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