UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008190 |
|---|---|
| Receipt number | R000009652 |
| Scientific Title | Effects of balance exercise and trunk & leg training for the prevention of falls |
| Date of disclosure of the study information | 2012/06/18 |
| Last modified on | 2013/04/09 17:34:07 |
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Basic information
Public title
Effects of balance exercise and trunk & leg training for the prevention of falls
Acronym
Effects of balance exercise and trunk & leg training for the prevention of falls
Scientific Title
Effects of balance exercise and trunk & leg training for the prevention of falls
Scientific Title:Acronym
Effects of balance exercise and trunk & leg training for the prevention of falls
Region
| Japan |
Condition
Condition
day care service users
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of exercise for the prevention of falls in day care service users
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fall frequency
Fracture frequency
Key secondary outcomes
Barthel Index, grip strength, standing time on one foot with eyes open, Timed Up & Go Test, 5-meter walk test, functional reach test, Berg Balance Scale, Falls efficacy scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Six-month balance and squat exercises in addition to conventional exercises
Interventions/Control_2
Only conventional exercises, no balance and squat exercises
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Kensyokai group day care service users who gave the consent to join this study
Key exclusion criteria
*Users who did not want to join this study
*Users who are prohibited from doing exercises by the physician
*Users who cannot do balance and squat exercises because of severe cognitive dysfunction
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Katoh |
Organization
The University of Tokushima
Division name
Division of Rehabilitation, Tokushima University Hospital
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nori Sato |
Organization
The University of Tokushima
Division name
Division of Rehabilitation, Tokushima University Hospital
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
Homepage URL
Sponsor or person
Institute
The University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
Social Welfare Corporation Kensyokai
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kensyokai group
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | 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
| 2012 | Year | 06 | Month | 18 | Day |
Last modified on
| 2013 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009652
| 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 |
