UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of exercise on cognitive functions in the elderly adults with mild cognitive impairment: a randomized controlled trial
Title of the study (Brief title)	A randomized control trial for preventing decline of cognitive functions in the elderly with MCI
Region	Japan

Condition
Condition	mild cognitive impairment
Classification by specialty	Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To examine the effects of physical exercise on cognitive decline in elderly with mild cognitive impairment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive function: Wechsler Memory Scale-Revised Logical Memory , Rey Auditory Verbal Learning Test, word list memory
Key secondary outcomes	Cognitive function: Digit span, modified digit symbol substitution test, verbal fluency, modified trail making test, flanker test, backward counting Brain volumetry: MRI Brain function: FDG PET and fNIRS Physical function: muscle strength, gait analysis, six minutes walk, balance control Activity: Tokyo Metropolitan Institute of Gerontology Index of Competence, Life-space assessment, Physical Activity Scale for the Elderly, pedometer Health related characteristics: apathy, pain, fall, QOL, Pittsburgh Sleep Quality Index, fall efficacy scale, gait efficacy scale, social activity

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group: Supervised exercise for 1 year
Interventions/Control_2	Control group: Lecture about disease and health (3 times per year)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Elderly people, aged 65 over and living in Obu city, having health check from Aug in 2011 to Feb in 2012. 2) Fullfilled Peterson's criteria (a: cognitive function is 1.5 SD or more below the normative values; b: score of more than 24 on the Mini-Mental State Examination; c: not diagnosed dementia; d: being independent in activity of daily living; e: having a complain of subjective memory problem) 3) Being agreed with participation in the study
Key exclusion criteria	1) Having serious or unstable illnesses 2) History of psychiatric disease 3) Receiving of anti-Alzheimer drugs 4) Geriatrics Depression Scale > 5 5) Needing long-term care
Target sample size	308

Research contact person
Name of lead principal investigator	Suzuki Takao
Organization	National Center for Geriatrics and Gerontology
Division name	Research Institute
Address	35 Gengo, Moriokacho, Obu, Aichi, 474-8511, Japan
TEL	0562445651
Email	jiritsu@ncgg.go.jp

Public contact
Name of contact person	Shimada Hiroyuki
Organization	National Center for Geriatrics and Gerontology
Division name	Department for Research and Development to Support Independent Life of Elderly
Address	35 Gengo, Moriokacho, Obu, Aichi, 474-8511, Japan
TEL	0562445651
Homepage URL
Email	jiritsu@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ministry of Health, Labour and Welfare (Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Ministry of Education Science and Culture of Japan.

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	大府市市内の施設

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 12 Month 24 Day
Anticipated trial start date	2012 Year 01 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	2012 Year 04 Month 13 Day
Last modified on	2016 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009121