UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012058 |
|---|---|
| Receipt number | R000014093 |
| Scientific Title | Study of fall prevention among community-dwelling elderly |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2015/06/18 11:11:22 |
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Basic information
Public title
Study of fall prevention among community-dwelling elderly
Acronym
Fall prevention among community-dwelling elderly
Scientific Title
Study of fall prevention among community-dwelling elderly
Scientific Title:Acronym
Fall prevention among community-dwelling elderly
Region
| Japan |
Condition
Condition
Falling
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of walking on falls among low-risk community-dwelling older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Fall rate, fall risk by exposer at 1 year from intervention
Key secondary outcomes
Fall-related physical function, activity, self-efficacy, blood pressure, ADL, dual task ability after 3-month intervention
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Walking
Interventions/Control_2
Balance exercise, lower extremity strength training, Tai Chi
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
| 65 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) aged between 65 to 79 years, (2) not care-needed or support-needed in Japanese long-term care insurance system, (3) not restricted by a doctor to exercise, and (4) without regular exercise habits
Key exclusion criteria
(1) high risk of falling (use of walking aid, having knee pain, using 4 or more medications, and history of falls in the previous year), (2) unable to participate in either of the two classes (walking or balance), (3) participated in other clinical trial during the past year.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoji Tanaka |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan
TEL
+81-29-853-5600(8365)
tanaka@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiro OKUBO |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Sciences
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan
TEL
+81-29-853-5600(8365)
Homepage URL
Yoshiro_okubo@stat.taiiku.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
筑波大学総合研究棟D（茨城県）/Laboratory of Advanced Research D/(Ibaraki)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25613322
Number of participants that the trial has enrolled
Results
The present findings suggest that walking among community-dwelling older adults can be more effective for fall prevention than balance training. However, because walking can induce more trips, walking should not be recommended for older adults who are susceptible to falling or frailty.
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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 15 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 17 | Day |
Last modified on
| 2015 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014093
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
