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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035097
Receipt No. R000039984
Official scientific title of the study Effect of exercise for dementia including early onset dementia and mild cognitive impairment
Date of disclosure of the study information 2018/12/01
Last modified on 2018/12/01

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Basic information
Official scientific title of the study Effect of exercise for dementia including early onset dementia and mild cognitive impairment
Title of the study (Brief title) Effect of exercise for dementia including early onset dementia and mild cognitive impairment
Region
Japan

Condition
Condition mild cognitive impairment:MCI
frontotemporal dementia:FTD
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to determine the effect of exercise, and evaluate the inhibitive effect of cognitive decline for dementia and MCI.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes MMSE
Key secondary outcomes MCI
1 Examination of cognitive
Magnetic resonance imaging
Change of brain blood flow by fNIRS
Clinical dementia rating
Geriatric depression scale
Wecheler memory scale-reviced
2 Blood test
Measured data of peptide markers and its related proteins
3 basic information
3-1 sex,age,height,weight,body composition,disease,joint pain medicine,education,depression,the years passed after diagnosis of dementia,family status,activities of daily living,quality of life

FTD,NDC
1Examination of cognitive
Magnetic resonance imaging
Single photon emission computed tomography
Change of brain blood flow by fNIRS
Clinical dementia rating
Geriatric depression scale
Frontal assessment battery
2 BPSD
Stereotypy Rating Inventory
Apathy evaluation scale
3 basic information
3-1 sex,age,height,weight,body composition,disease,joint pain medicine,education,depression,the years passed after diagnosis of dementia,family status,activities of daily living,quality of life
3-2 Zarit Care burden standard (J-ZBI _8)
Japanese Version of the Zarit Caregiver Burden Interview
3-3 performance tests
muscle strength (grip,lower muscle),balance,gait speed (usual gait speed,6 minutes walk test),flexibility,dexterity
3-4 endurance
Vo2max is evaluated using bicycle ergometer.
3-5 medicine
information from medicine log
3-6 Sleep condition
Actigraph
3-7 Physical activity
physical activity is assessed by 3-axis accelerometer (HJA-750C, OMRON)
3-8 biochemical examination
I direct it to refrain from the meals within 12 hours and collect blood in a hunger state. I perform the drawing blood before and after intervention.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Interventions MCI
Training muscle strength
Intervention period 12 months
Interventions/Control_2 Control MCI
No treatment
Intervention period 12 months
Interventions/Control_3 Interventions FTD
Training bicycle ergometer
Intervention period 12 months
Interventions/Control_4 Control FTD
No treatment
Intervention period 12 months
Interventions/Control_5 Interventions NDC
Training bicycle ergometer
Intervention period 12 months
Interventions/Control_6 Control NDC
No treatment
Intervention period 12 months
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria Criteria for amnestic MCI
Type1 complaint of memory disturbance from the participant plus approval by the study partner
Type2 memory disturbance approved by the study partner, without the subjective complaint of the participant
MMSE 24-30
Scores of Wechsler memory Scale-R logical memory 2
corrected for education,
below the cut-off levels.
education 0-9 years 2 or lower
10-15 years 4 or lower
over 16 years 8 or lower
CDR 0.5 not depressed


Criteria for behavioural variant FTD
Criteria for Behavioral Variant FTD
Possible bvFTD
Three of the following behavioural cognitive symptoms A-F must be present to meet criteria.
A Early behavioural disinhibition
B Early apathy or inertia
C Early loss of sympathy or empathy
D Early perseverative,stereotyped or compulsive ritualistic behaviour
E Hyperorality and dietary changes
F Neuropsychological profile: executive/generation deficits with relative sparing of memory and visuospatial functions

Probable bvFTD
All of the following symptoms
A-C must be present to meet criteria.
A Meets criteria for possible bvFTD
B Exhibits significant functional decline
C Imaging results consistent with bvFTD
Key exclusion criteria 1Parkinson'disease, multiple cerebral infarction, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, head trauma with sequelae
2Signs of brain infection, focal brain lesions(eg infarction)that may affect cognitive function.
3Presence of pacemaker, arterial clip, artificial valves, artificial cochlea, and other magnetic/electroconductive metals in the body that may affect MRI
4Major depression or bipolar disorder within past 1 year, addiction to alcohol or other drugs within past 2 years, presence of fatal or unstable diseases, vitamin B12 or folate deficiency, syphilis, thyroid function abnormality
5Administration of psychoactive drugs (defined in procedure manual)
6Administration of warfarin
7Participant in clinical trial of new AD therapeutic drug
8Clinical Judgment Committee
9Participant with impaired ADL
Target sample size 60

Research contact person
Name of lead principal investigator Tetsuaki ARAI
Organization University of Tsukuba
Division name Department of Neuropsychiatry,Division of Clinical Medicine,Faculty of Medicine
Address 1-1-1Tennoudai,Tsukuba,Ibaraki,Japan
TEL 029-853-3182
Email 4632tetsu@md.tsukuba.ac.jp

Public contact
Name of contact person Tetsuaki ARAI
Organization University of Tsukuba
Division name Department of Neuropsychiatry,Division of Clinical Medicine,Faculty of Medicine
Address 1-1-1Tennoudai,Tsukuba,Ibaraki,Japan
TEL 029-853-3182
Homepage URL
Email 4632tetsu@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba Hospital
Institute
Department

Funding Source
Organization other
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Shimadzu Corporation
MCBI Corporation
Name of secondary funder(s) None

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 筑波大学附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 12 Month 01 Day
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 12 Month 01 Day
Last modified on
2018 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039984

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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