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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name