UMIN-CTR Clinical Trial

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
Institute	Tokyo saiseikai central hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032812