UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028663
Receipt number R000032812
Scientific Title Effects of multicomponent exercise including home exercise program on cerebral blood flow in older adults with mild cognitive impairment: a single-center, non-randomized controlled trial
Date of disclosure of the study information 2017/09/01
Last modified on 2020/08/16 18:36:50

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Basic information

Public title

Effects of multicomponent exercise including home exercise program on cerebral blood flow in older adults with mild cognitive impairment: a single-center, non-randomized controlled trial

Acronym

Effects of multicomponent exercise on cerebral blood flow in older adults with mild cognitive impairment

Scientific Title

Effects of multicomponent exercise including home exercise program on cerebral blood flow in older adults with mild cognitive impairment: a single-center, non-randomized controlled trial

Scientific Title:Acronym

Effects of multicomponent exercise on cerebral blood flow in older adults with mild cognitive impairment

Region

Japan


Condition

Condition

Amnestic mild cognitive impairment

Classification by specialty

Neurology Geriatrics Psychiatry
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of multicomponent exercise including home exercise program in older adults with mild cognitive impairment on cerebral image findings and cognitive function

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cerebral blood flow

Key secondary outcomes

Cognitive function, Physical function, Brain atrophy


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Dual task training combined exercise and cognitive task included home exercise education

Interventions/Control_2

Control group

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


Not applicable

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

A score of 0.5 in the Clinical Dementia Rating Scale Japanese
Diagnosis of amnestic mild cognitive impairment
The subject who has consent of principal or substitute person for research participation

Key exclusion criteria

Mini-Mental State Examination is less than 24 points
Diagnosis of dementia
The subject who have painful exerciser disease, cardiovascular disease and metabolic disease difficult to participate in class
Diagnosis of non-amnestic mild cognitive impairment
History of cerebrovascular disease
The subject who is in care residence

Target sample size

56


Research contact person

Name of lead principal investigator

1st name Yota
Middle name
Last name Kunieda

Organization

Juntendo Tokyo Koto Geriatric Medical Center

Division name

Department of Rehabilitation

Zip code

1360075

Address

3-3-20, Shinsuna, Koto-ku, Tokyo

TEL

03-5632-3111

Email

kunieda.999@gmail.com


Public contact

Name of contact person

1st name Yota
Middle name
Last name Kunieda

Organization

Juntendo Tokyo Koto Geriatric Medical Center

Division name

Department of Rehabilitation

Zip code

1360075

Address

3-3-20, Shinsuna, Koto-ku, Tokyo

TEL

03-5632-3111

Homepage URL


Email

kunieda.999@gmail.com


Sponsor or person

Institute

Tokyo saiseikai central hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The ethics committee of Tokyo Saiseikai Central Hospital

Address

1-4-17, Mita, Minato-ku, Tokyo

Tel

03-3451-8211

Email

tikenjimu@saichu.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

2017 Year 09 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

30

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Data analysis takes time

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 08 Month 31 Day

Date of IRB

2017 Year 07 Month 15 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 08 Month 31 Day

Date trial data considered complete

2019 Year 08 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 08 Month 15 Day

Last modified on

2020 Year 08 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032812


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name