UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044224 |
|---|---|
| Receipt number | R000050508 |
| Scientific Title | An exploratory study to evaluate the Non-pharmacological intervention for mild cognitive impairment |
| Date of disclosure of the study information | 2021/05/17 |
| Last modified on | 2024/07/09 14:33:10 |
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Basic information
Public title
Evaluation of Non-pharmacological Intervention for MCI patients
Acronym
Evaluation of Non-pharmacological Intervention for MCI patients
Scientific Title
An exploratory study to evaluate the Non-pharmacological intervention for mild cognitive impairment
Scientific Title:Acronym
Evaluation of Non-pharmacological Intervention for MCI patients
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Classification by specialty
| Neurology | Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of the non-pharmacological intervention in mild cognitive impairment (MCI). We conduct an educational program in which the patients receive the instructions including exercises and lifestyle improvements, and we investigate the changes in parameters such as cognitive abilities, activities of daily living, qualities of life, and family's burden.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
EQ-5D (EuroQol 5 Dimension)
Key secondary outcomes
Time up and go test
5-Cog (5-Cog Battery for Detecting Cognitive Impairment and Dementia)
Grip strength
MMSE (Mini-Mental State Examination)
Geriatric Depression Scale (GDS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
physical and cognitive intervention program including exercise, cognitive training, nutrition guidance, and education about dementia
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 50 to under 85 who were diagnosed with MCI at Kobe University Dementia Medical Center
2) Patients who spend with study partner over 10 hours per week
3) Patients who agree to visit the hospital regularly and receive the cognitive function test and questionnaire-style test
Key exclusion criteria
1) Patients who are restricted from exercising due to complications such as heart failure, renal failure, or paralysis
2) Patients who cannot provide the written consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hisatomo |
| Middle name | |
| Last name | Kowa |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2, Tomogaoka, Suma-ku, Kobe, Hyogo
TEL
078-796-4561
kowa@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisatomo |
| Middle name | |
| Last name | Kowa |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2, Tomogaoka, Suma-ku, Kobe, Hyogo
TEL
078-796-4561
Homepage URL
kowa@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
World Health Organization
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
Kobe University Graduate School of Health Sciences
Address
7-10-2, Tomogaoka, Suma-ku, Kobe, Hyogo
Tel
078-796-4502
syomu2@ams.kobe-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
| 2021 | Year | 05 | Month | 17 | 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
31
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
| 2017 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2021 | Year | 05 | Month | 17 | Day |
Last modified on
| 2024 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050508
