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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027395
Receipt No. 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 2019/05/20

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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
Email 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
Email akikane@tmghig.jp

Sponsor
Institute Tokyo Metropolitan Geriatric Hospital,
Department of Rehabilitaion
Institute
Department

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
Email 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
Results
The number of participants is 75, until November 2018
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 Open public recruiting
Date of protocol fixation
2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 15 Day
Last follow-up date
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
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031389

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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