UMIN-CTR Clinical Trial

Basic information
Public title	Longitudinal Study for Prevention of Dementia and Sarcopenia by Physical Assessment and Intervention in Community-Dwelling Elderly: Fukuoka-Island-city Study
Acronym	Fukuoka-Island-city Study
Scientific Title	Longitudinal Study for Prevention of Dementia and Sarcopenia by Physical Assessment and Intervention in Community-Dwelling Elderly: Fukuoka-Island-city Study
Scientific Title:Acronym	Fukuoka-Island-city Study
Region	Japan

Condition
Condition	Community-dwelling elderly
Classification by specialty	Geriatrics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of exercise and daily physical activity on prevention of dementia and sarcopenia in the community-dwelling elderly
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Total energy expenditure, physical activity, muscle strength, physical and cognitive function after 3 month exercise intervention. Muscle mass, muscle strength, physical and cognitive function following years.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Exercise intervention at cardiac oxygen demand threshold
Interventions/Control_2	No intervention with scheduled assessments
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) community dwelling elderly aged (No age limit)2) listed in basic resident register network in Fukuoka-shi, Fukuoka, Japan and live within 2 km of Island City Central Park (walking distance)
Key exclusion criteria	1) designated as physical or mental disability certificate by the public administration at the beginning of the study 2) designated as a person requiring long-term care or support by the Long-Term Care Insurance Act at the beginning of the study 3) out-migrated or deceased person at the day of sending the mail
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Hiroaki Middle name Last name Tanaka
Organization	Fukuoka University
Division name	Institute for Physical Activity
Zip code	814-0180
Address	8-19-1 Nanakuma, Jonan-ku, Fukuoka, Japan
TEL	092-871-6631
Email	htanaka@fukuoka-u.ac.jp

Public contact
1st name of contact person	1st name Yoichi Middle name Last name Hatamoto
Organization	Fukuoka University
Division name	Institute for Physical Activity
Zip code	814-0180
Address	8-19-1 Nanakuma, Jonan-ku, Fukuoka, Japan
TEL	092-871-6631
Homepage URL
Email	monkeymatuyama@yahoo.co.jp

Sponsor
Institute	Fukuoka University, Institute for Physical Activity
Institute
Department

Funding Source
Organization	Fukuoka University, Institute for Physical Activity
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukuoka University
Address	8-19-1 Nanakuma, Jonan-ku, Fukuoka, Japan
Tel	092-871-6631
Email	pj.ca-u-akoukuf.mda@nisius

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	2019 Year 05 Month 06 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	58
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	No longer recruiting
Date of protocol fixation	2015 Year 04 Month 15 Day
Date of IRB	2015 Year 04 Month 15 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2020 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 06 Day
Last modified on	2019 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041766