UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028352 |
|---|---|
| Receipt number | R000032456 |
| Scientific Title | The effect of a tailor-made programs on fall prevention in community-dwelling elderly |
| Date of disclosure of the study information | 2017/07/31 |
| Last modified on | 2020/07/29 14:25:03 |
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Basic information
Public title
The effect of a tailor-made programs on fall prevention in community-dwelling elderly
Acronym
Tailor-made fall prevention
Scientific Title
The effect of a tailor-made programs on fall prevention in community-dwelling elderly
Scientific Title:Acronym
Tailor-made fall prevention
Region
| Japan |
Condition
Condition
community-dwelling elderly
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of a tailor-made program on fall prevention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
one-year fall rate after a tailor-made program for fall prevention
Key secondary outcomes
1)gait function
2)foot function
3)muscle thickness
4)muscle mass
5)internal fat
6)balance ability
7)fear of fall
8)nutritinal status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A tailor-made program for fall prevention for one year
Interventions/Control_2
General program for fall prevention for one year
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
community dwelling elderly who walk independently
Key exclusion criteria
1) individuals being prohibited from exercising by doctor
2) individuals decreased cognitive function due to cerebrovascular disease and Alzheimer's disease
3) individuals with acute orthopedic pain and neurological symptom
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Asai |
Organization
Kobegakuin University
Division name
Faculty of rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadanicho, Nishiku, Kobe city, Hyogo
TEL
078-974-2461
asai@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Asai |
Organization
Kobegakuin University
Division name
Faculty of rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadanicho, Nishiku, Kobe city, Hyogo
TEL
078-974-2461
Homepage URL
asai@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kobegakuin University
Institute
Department
Personal name
Funding Source
Organization
Kobegakuin University
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
Kobegakuin University
Address
518 Arise, Ikawadanicho, Nishiku, Kobe city, Hyogo
Tel
078-974-4297
kenkyu@j.kobegakuin.ac.jp
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
| 2017 | Year | 07 | Month | 31 | 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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | 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
| 2017 | Year | 07 | Month | 24 | Day |
Last modified on
| 2020 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032456
