UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005799 |
|---|---|
| Receipt number | R000006707 |
| Scientific Title | Longitudinal Study for Prevention of Dementia and Sarcopenia by Physical Assessment and Intervention in Community-Dwelling Elderly: Fukuoka-Nakagawa Study |
| Date of disclosure of the study information | 2011/06/19 |
| Last modified on | 2014/01/27 11:08:20 |
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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-Nakagawa Study
Acronym
Fukuoka-Nakagawa Study
Scientific Title
Longitudinal Study for Prevention of Dementia and Sarcopenia by Physical Assessment and Intervention in Community-Dwelling Elderly: Fukuoka-Nakagawa Study
Scientific Title:Acronym
Fukuoka-Nakagawa Study
Region
| Japan |
Condition
Condition
Healthy community-dwelling elderly including mild cognitive impairment
Classification by specialty
| Neurology | Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the effect of exercise and daily physical activity on prevention of dementia and sarcopenia in the healthy community-dwelling elderly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
skeletal muscle mass and strength, and physical and cognitive function at 6 month and 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 not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise intervention at cardiac oxygen demand threshold for mild cognitive impairment
Interventions/Control_2
Intervention with stretching and lower intensity activities for mild cognitive impairment
Interventions/Control_3
Exercise intervention at cardiac oxygen demand threshold for normal cognitive elderly
Interventions/Control_4
No intervention with scheduled assessments for normal cognitive elderly
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) community dwelling elderly aged 65-99 years old
2) listed in basic resident register network in Nakagawa-cho, Fukuoka, Japan
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
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Tanaka |
Organization
Fukuoka University
Division name
Institute for Physical Activity
Zip code
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 | |
| Middle name | |
| Last name | Hiroaki Tanaka |
Organization
Fukuoka University
Division name
Institute for Physical Activity
Zip code
Address
8-19-1 Nanakuma, Jonan-ku, Fukuoka, Japan
TEL
092-871-6631(6767)
Homepage URL
htanaka@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Institute for Physical Activity
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Education, Culture, Sports, Science & Technology in Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nakagawa-cho, Fukuoka Prefecture
Department of Neurology, Faculty of Medicine, Fukuoka University
Fukuseikai Hospital
Kyoto Prefectural University of Medicine
Name of secondary funder(s)
The Uehara Memorial Foundation
Fukuoka University
Nakagawa-cho, Fukuoka Prefecture
IRB Contact (For public release)
Organization
Address
Tel
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
那珂川町保健センター、福祉センター、福岡大学病院、福西会病院、福岡大学スポーツ科学部（福岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 19 | 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
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
| 2011 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 18 | Day |
Last modified on
| 2014 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006707
| 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 |
