UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040125 |
|---|---|
| Receipt number | R000045714 |
| Scientific Title | Effective of group activity for elderly persons who declined cognitive function in convalescent ward |
| Date of disclosure of the study information | 2020/04/10 |
| Last modified on | 2023/04/13 13:56:49 |
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Basic information
Public title
Effects of group activities on cognitive functions of the elderly in convalescent wards
Acronym
Effects of group activities on maintenance and improvement of cognitive function in the elderly
Scientific Title
Effective of group activity for elderly persons who declined cognitive function
in convalescent ward
Scientific Title:Acronym
Effective of group activity for elderly persons who declined cognitive function
in convalescent ward
Region
| Japan |
Condition
Condition
Dementia, Mild Cognitive Impairment
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effectiveness of group activity using IroKaruta for elderly persons with declined cognitive function in convalescent ward.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NPI-NH
Key secondary outcomes
MMSE,FIM,MOHOST,ACIS,VQ
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group receive a regular rehabilitation program and 30-40 minutes of group activity using IroKaruta twice a week for 4 weeks.
Interventions/Control_2
The control group receive a regular rehabilitation program and 30-40 minutes of recreation twice a week for 4 weeks.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study participants comprise elderly subjects aged 65 years and older with decline in cognitive function and orthopedic diseases in a convalescent rehabilitation ward. The inclusion criteria were a Mini Mental State Examination(MMSE)s' score of 10-26 points, the ability to sit for more than 30 minutes, and to communication by language.
Key exclusion criteria
Exclusion criteria were those who had difficulty communicating by language and who had a mental disease.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Natumi |
| Middle name | |
| Last name | Kimura |
Organization
Tokyo Metropolitan University
Division name
Department of Occupational Therapy, Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10,Higashi-ogu,Arakawa-ku,Tokyo,Japan
TEL
03-3819-1211(ext.454)
kodama-natsumi1@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | Norikazu |
| Middle name | |
| Last name | Kobayashi |
Organization
Tokyo Metropolitan University
Division name
Department of Occupational Therapy, Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10,Higashi-ogu,Arakawa-ku,Tokyo,Japan
TEL
03-3819-1211(ext.454)
Homepage URL
n-koba@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University Arakawa campus IRB
Address
7-2-10,Higashi-ogu,Arakawa-ku,Tokyo,Japan
Tel
03-3819-1211(ext.215)
rinri-hs@tmu.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
| 2020 | Year | 04 | Month | 10 | 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
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
Suspended
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | 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 | 04 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045714
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
