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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028352
Receipt No. 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 2017/07/24

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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
Middle name
Last name Tsuyoshi Asai
Organization Kobegakuin University
Division name Faculty of rehabilitation
Zip code
Address 518 Arise, Ikawadanicho, Nishiku, Kobe city, Hyogo
TEL 078-974-2461
Email asai@reha.kobegakuin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Asai
Organization Kobegakuin University
Division name Faculty of rehabilitation
Zip code
Address 518 Arise, Ikawadanicho, Nishiku, Kobe city, Hyogo
TEL 078-974-2461
Homepage URL
Email asai@reha.kobegakuin.ac.jp

Sponsor
Institute Kobegakuin University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2020 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2020 Year 04 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
2017 Year 07 Month 24 Day
Last modified on
2017 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032456

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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