UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013674
Receipt number R000015962
Scientific Title The effectiveness of health promotion programs for the community-dwelling elderly people: A prospective study
Date of disclosure of the study information 2014/04/09
Last modified on 2014/04/09 08:30:18

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Basic information

Public title

The effectiveness of health promotion programs for the community-dwelling elderly people: A prospective study

Acronym

The effectiveness of health promotion programs for the community-dwelling elderly people: A prospective study

Scientific Title

The effectiveness of health promotion programs for the community-dwelling elderly people: A prospective study

Scientific Title:Acronym

The effectiveness of health promotion programs for the community-dwelling elderly people: A prospective study

Region

Japan


Condition

Condition

Community-dwelling elderly people

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether health promotion programs for the community-dwelling elderly can prolong the healthy life expectancy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The number of the person who requires nursing care in the whole community population (T city)
The scores of questionnaire of functioning

Key secondary outcomes

The number of participants who join the health promotion programs or the educating programs

The various other measures evaluated in health promotion programs: physical measures, cognitive measures etc.


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

The health promotion programs in the community: evaluation of various functions and feedback, and teaching exercises. The educating program for the elderly who will be the leader of the health promotion programs.

Interventions/Control_2


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

Dwelling in the community

Key exclusion criteria

Nursing home residents
Patients in the hospital

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yohei Otaka

Organization

Keiyu Orhopaedic Hospital

Division name

Center for fall and fracture prevention

Zip code


Address

1741 Hanetsuku-chou, Tatebayashi, Gunma, Japan

TEL

0276-72-6000

Email

otaka119@mac.com


Public contact

Name of contact person

1st name
Middle name
Last name Yohei Otaka

Organization

Keiyu Orhopaedic Hospital

Division name

Center for fall and fracture prevention

Zip code


Address

1741 Hanetsuku-chou, Tatebayashi, Gunma, Japan

TEL

0276-72-6000

Homepage URL


Email

otaka119@mac.com


Sponsor or person

Institute

Keiyu Orthopaedic Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2014 Year 04 Month 09 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

Open public recruiting

Date of protocol fixation

2014 Year 03 Month 28 Day

Date of IRB


Anticipated trial start date

2014 Year 04 Month 09 Day

Last follow-up date

2024 Year 04 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 04 Month 09 Day

Last modified on

2014 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=R000015962


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name