UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062151 |
|---|---|
| Receipt number | R000071126 |
| Scientific Title | Standardized exercise intervention for patients with schizophrenia: Feasibility and preliminary cognitive outcomes of a pilot randomized controlled trial |
| Date of disclosure of the study information | 2026/07/06 |
| Last modified on | 2026/07/06 21:46:32 |
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Basic information
Public title
Standardized exercise intervention for patients with schizophrenia: Feasibility and preliminary cognitive outcomes of a pilot randomized controlled trial
Acronym
Standardized exercise intervention for patients with schizophrenia: Feasibility and preliminary cognitive outcomes of a pilot randomized controlled trial
Scientific Title
Standardized exercise intervention for patients with schizophrenia: Feasibility and preliminary cognitive outcomes of a pilot randomized controlled trial
Scientific Title:Acronym
Standardized exercise intervention for patients with schizophrenia: Feasibility and preliminary cognitive outcomes of 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 test feasibility, safety, adherence, and preliminary cognitive outcomes of a standardized yet flexible exercise program in patients with schizophrenia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility outcomes
Key secondary outcomes
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 |
Interventions/Control_1
Exercise intervention
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) age 18-60 years
(2) a diagnosis of schizophrenia confirmed by the Structured Clinical Interview for DSM-5 Disorders Research Version
Key exclusion criteria
(1) a current primary DSM-5 diagnosis other than schizophrenia
(2) history of mental retardation
(3) history of neurological disorder
(4) significant drug or alcohol abuse within 6 months prior to consent
(5) psychosis secondary to substance abuse
(6) current risk of suicide or a history of suicidal behavior within 6 months prior to consent
(7) the presence of comorbid serious physical disorder
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Shiamda |
Organization
Medical Corporation Yuaikai Tikumaso Mental Hospital
Division name
Department of Day-care
Zip code
386-8584
Address
4-61, Chuo-higashi, Ueda, Nagano, Japan
TEL
0268-22-6611
takeshi_shimada@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Shimada |
Organization
Medical Corporation Yuaikai Tikumaso Mental Hospital
Division name
Department of Day-care
Zip code
386-8584
Address
4-61, Chuo-higashi, Ueda, Nagano, Japan
TEL
0268-22-6611
Homepage URL
takeshi_shimada@shinshu-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Yuaikai Tikumaso Mental Hospital
Address
4-61, Chuo-higashi, Ueda, Nagano, Japan
Tel
0268-22-6611
takeshi_shimada@shinshu-u.ac.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
| 2026 | Year | 07 | Month | 06 | 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
41
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 06 | Day |
Last modified on
| 2026 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071126
