UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036659 |
|---|---|
| Receipt number | 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 16:03:47 |
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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
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
monkeymatuyama@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University, Institute for Physical Activity
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
