UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023083 |
|---|---|
| Receipt number | R000026488 |
| Scientific Title | Effects of group physical activity based on brain-activating rehabilitation for dementia in geriatric health service facilities |
| Date of disclosure of the study information | 2016/07/08 |
| Last modified on | 2022/10/07 09:57:45 |
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Basic information
Public title
Effects of group physical activity based on brain-activating rehabilitation for dementia in geriatric health service facilities
Acronym
Group physical activity for dementia in geriatric health service facilities
Scientific Title
Effects of group physical activity based on brain-activating rehabilitation for dementia in geriatric health service facilities
Scientific Title:Acronym
Group physical activity for dementia in geriatric health service facilities
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Geriatrics | Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine effects of group physical activity for dementia in geriatric health facilities.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
This study includes some outcomes indicated below after 12 weeks from first intervention sessions.
Change of life space in daily living
Change of physical activity amount level
Change of global cognitive function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and 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
| Maneuver |
Interventions/Control_1
Participants will be received physical activity on group setting for 45-60 minutes, twice a week, for a 12-week period, in addition be received usual care.
Interventions/Control_2
Participants will not be received intervention from intervention staffs, while they receive assistance of daily living and individualized rehabilitation about twice a week.
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
1. Having dementia with mini-mental statement examination (MMSE) score of 5 to 25,
2. being able to engage in a simple activity or a brief conversation
Key exclusion criteria
1. Having severe auditory and visual impairments,
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tanaka Shigeya |
Organization
Takasaki Univesity of Health and Welfare
Division name
Department of Psysical therapy, Faculty of Health care
Zip code
Address
501 Nakaoruicho, Takasaki City, Gunma
TEL
027-352-1291
tanaka-s@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tanaka Shigeya |
Organization
Takasaki University of Health and Welfare
Division name
Department of Physical therapy, Faculty of Health care
Zip code
Address
501 Nakaoruicho, Takasaki City, Gunma
TEL
027-352-1291
Homepage URL
tanaka-s@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
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
Address
Tel
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
| 2016 | Year | 07 | Month | 08 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
2016.8.8 Baseline assessment : 1st period
2016.8.22 Interventions were started : 1st period
2016.11.11 Interventions were completed : 1st period
2016.11.14 Second assessment : 1st period
Management information
Registered date
| 2016 | Year | 07 | Month | 08 | Day |
Last modified on
| 2022 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026488
