UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027395 |
|---|---|
| Receipt number | R000031389 |
| Scientific Title | The construction of an effective program for those with mild cognitive impairment or mild dementia: the direct and spreading effect of a short-term intensive training |
| Date of disclosure of the study information | 2017/05/18 |
| Last modified on | 2021/06/18 11:20:42 |
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Basic information
Public title
The construction of an effective program for those with mild cognitive impairment or mild dementia: the direct and spreading effect of a short-term intensive training
Acronym
An Intervention Study of Rehabilitation Program Using Physical and Cognitive Rec-Xercise for Mild Cognitive Impairment and mild demantia
Scientific Title
The construction of an effective program for those with mild cognitive impairment or mild dementia: the direct and spreading effect of a short-term intensive training
Scientific Title:Acronym
An Intervention Study of Rehabilitation Program Using Physical and Cognitive Rec-Xercise for Mild Cognitive Impairment and mild demantia
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Mild dementia
Classification by specialty
| Neurology | Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a rehabilitation program (physical and cognitive Rec-Xercise) which focuses not on simple memory function but on executive function for mild cognitive impairment (MCI) and mild dementia, we investigate whether the program can lower the reduction speed of their physical and cognitive abilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
When:
before and right after the intervention,
3, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months after the intervention
Outcome measure: MMSE total score
Key secondary outcomes
MMSE total score, MoCA total score, RBMT, RCPM, TMTA & TMTB
POMS
TMIG-index of competence, JST
SF36
6MD, TUG, Grip strength
MRI
Nutrition
Laboratory data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The cognitive Rec-Xercise group (A):
subjects receive the session once per week up to 12 times. During the intervention period, the subjects were required to do everyday home-work.
After the intervention, they receive the one day-booster with 7 days home-work at every follow-up.
Interventions/Control_2
Physical Rec-Xercise group (B):
subjects receive the session once per week up to 12 times. During the intervention period, the subjects were required to do everyday home-work.
After the intervention, they receive the one day-booster with 7 days home-work at every follow-up.
Interventions/Control_3
Both cognitive and physical Rec-Xercise group (C):
subjects receive the session once per week up to 12 times. During the intervention period, the subjects were required to do everyday home-work.
After the intervention, they receive the one day-booster with 7 days home-work at every follow-up.
Interventions/Control_4
Control group:
they receive only lecture for health care a couple of times a year.
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
MMSE total score is above 20
Key exclusion criteria
1) Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, corticobasal degeneration, epilepsy, subdural hematoma, multiple sclerosis, traumatic brain injury with cognitive impairment
2) Cerebrovascular disease with responsible lesions of cognitive impairment on MRI
3) Schizophrenia, major depressive or bipolar episode during the past year, alcohol or drug addiction for the past two years, vitamin B12 deficiency, folate deficiency, syphilis, thyroid dysfunction
4) Apparent mental retardation or suspicious mental retardation
5) The case not qualified for the study by the principal investigator
Target sample size
256
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Kanemaru |
Organization
Tokyo Metropolitan Geriatric Hospital
Division name
Department of Rehabilitation
Zip code
173-0015
Address
35-2, Sakae-Cho, Itabashi-Ku, Tokyo
TEL
0339641141
akikane@tmghig.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Yoshioka |
Organization
Tokyo Metropolitan Geriatric Hospital
Division name
Clinical Research Support Center
Zip code
173-0015
Address
35-2, Sakae-Cho, Itabashi-Ku, Tokyo
TEL
0339641141
Homepage URL
akikane@tmghig.jp
Sponsor or person
Institute
Tokyo Metropolitan Geriatric Hospital,
Department of Rehabilitaion
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Geriatric Hospital
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
HAIC: Healthy Aging Innovation Center
Address
35-2, Sakae-Cho, Itabashi-Ku, Tokyo
Tel
03-3964-1141
rinsyoushiken@tmghig.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
東京都健康長寿医療センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
98
Results
The number of participants is 98, until May 2021
Results date posted
| 2019 | Year | 12 | Month | 26 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
It takes more time to reach the target sample-size.
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2017 | Year | 05 | Month | 18 | Day |
Last modified on
| 2021 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031389
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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