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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036659
Receipt No. R000041766
Scientific Title Longitudinal Study for Prevention of Dementia and Sarcopenia by Physical Assessment and Intervention in Community-Dwelling Elderly: Fukuoka-Island-city Study
Date of disclosure of the study information 2019/05/06
Last modified on 2019/05/06

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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