UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038201 |
|---|---|
| Receipt number | R000043540 |
| Scientific Title | Examination of improvement effect of psychiatric symptoms by combined use of psychiatric occupational therapy and exercise therapy: a hospital-based RCT |
| Date of disclosure of the study information | 2019/10/10 |
| Last modified on | 2020/11/13 10:50:40 |
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Basic information
Public title
Examination of improvement effect of psychiatric symptoms by combined use of psychiatric occupational therapy and physical exercise
Acronym
Examination of improvement effect of psychiatric symptoms by combined use of psychiatric occupational therapy and physical exercise
Scientific Title
Examination of improvement effect of psychiatric symptoms by combined use of psychiatric occupational therapy and exercise therapy: a hospital-based RCT
Scientific Title:Acronym
Examination of improvement effect of psychiatric symptoms by combined use of psychiatric occupational therapy and exercise therapy: a hospital-based RCT
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of improvement effect of psychiatric symptoms by combined use of psychiatric occupational therapy and physical exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neuropsychiatric Inventory Nursing Home Version(NPI-NH)
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 | Maneuver |
Interventions/Control_1
Case:occupational therapy(5 days/w , 1 set/day , 120 min/set) and physical exercise(5 days/week , 2 set/day , 20 min/set) for 2 weeks
Interventions/Control_2
Control:occupational therapy(5 days/w , 1 set/day , 120 min/set)
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosis of dementia (DSM-5)
Key exclusion criteria
Under 60 years old
Persons with movement disorders or diseases that interfere with ergometer driving
Delirium
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Takebayashi |
Organization
Kumamoto University
Division name
Department of Neuropsychiatry Faculty of Life Sciences
Zip code
860-8556
Address
1-1-1,Honjo,Chuo-ku,Kumamoto
TEL
096-373-5184
mtakebayashi@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Yoshiura |
Organization
Kumamoto University Hospital
Division name
Department of Neuropsychiatry
Zip code
860-8556
Address
1-1-1,Honjo,Chuo-ku,Kumamoto
TEL
096-373-5184
Homepage URL
kazuzak@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Japanese association of occupational Therapists
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
Kumamoto University Clinical Research Ethics Committee
Address
1-1-1,Honjo,Chuo-ku,Kumamoto
Tel
096-373-5657
ski-shien@jimu.kumamoto-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
| 2019 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.jaot.or.jp/files/page/wp-content/uploads/2019/12/kadai-2019-02.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://www.jaot.or.jp/files/page/wp-content/uploads/2019/12/kadai-2019-02.pdf
Number of participants that the trial has enrolled
17
Results
Statistical analysis revealed that there were no significant differences in the subject's profile between the two groups. The two-group comparison of therapeutic effects was analyzed by repeated measures two-way ANOVA, and no significant difference was found in MENFIS (p= 0.34), NPI-NH(p= 0.34), Behave-AD(p=0.53), and DAD(p=0.67).
Results date posted
| 2020 | Year | 11 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were inpatients at Kumamoto University Hospital, Department of Neuropsychiatry and Kumamoto Seimei Hospital, who were diagnosed with dementia based on the DSM-5 criteria and were over 60 years old. The subjects were those who could perform the Timed Up and Go Test (TUG). For the subjects who completed the survey, the characteristics of the intervention group (n = 10) were 79.1 years old, female rate 50.0%, and MMSE score 17.4 points. The control group (n = 7) was 75.9 years old, female rate was 14.3 %, and the MMSE score was 18.9 points.
Participant flow
Subjects were randomly assigned to receive interventions with a combination of exercise and occupational therapy and controls with occupational therapy only. The allocation method was a central registration method. Stratification was performed after considering age, gender ratio, MMSE score, and type of dementia. The number of participants was 18. Of these, 17 completed treatment as planned.
Adverse events
Not in particular.
Outcome measures
The initial evaluation was performed before the intervention (3 days before to the day).
The final evaluation was made after 2 weeks of intervention (from the day to 3 days later).
Four types of neuropsychological evaluations were used to determine the effect of this study.
The Mental Function impairment Scale (MENFIS) and Neuropsychiatric Inventory Nursing Home Version (NPI-NH) were used to evaluate neuropsychiatric symptoms. Behavioral Pathology in Alzheimer's Disease (Behave-AD) was used to assess behavioral disorders in dementia. The Disability Assessment for Dementia (DAD) was used to evaluate the daily living ability of patients with dementia.
Plan to share IPD
Not in particular.
IPD sharing Plan description
Not in particular.
Progress
Recruitment status
Suspended
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is difficult to continue the investigation due to the influence of COVID-19.
Management information
Registered date
| 2019 | Year | 10 | Month | 04 | Day |
Last modified on
| 2020 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043540
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| Registered date | File name |
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