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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000038201
Receipt No. 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

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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
Email 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
Email kazuzak@kuh.kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043540

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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