UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035097 |
|---|---|
| Receipt number | R000039984 |
| Scientific Title | 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 10:05:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of exercise for dementia including early onset dementia and mild cognitive impairment
Acronym
Effect of exercise for dementia including early onset dementia and mild cognitive impairment
Scientific Title
Effect of exercise for dementia including early onset dementia and mild cognitive impairment
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tetsuaki ARAI |
Organization
University of Tsukuba
Division name
Department of Neuropsychiatry,Division of Clinical Medicine,Faculty of Medicine
Zip code
Address
1-1-1Tennoudai,Tsukuba,Ibaraki,Japan
TEL
029-853-3182
4632tetsu@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuaki ARAI |
Organization
University of Tsukuba
Division name
Department of Neuropsychiatry,Division of Clinical Medicine,Faculty of Medicine
Zip code
Address
1-1-1Tennoudai,Tsukuba,Ibaraki,Japan
TEL
029-853-3182
Homepage URL
4632tetsu@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
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
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039984
