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

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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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name