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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044224
Receipt No. 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 2021/05/17

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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
Email 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
Email kowa@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

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
Email 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 No longer recruiting
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
2021 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050508

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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