UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000054005
Receipt number R000061659
Scientific Title Social implementation and effectiveness of a web-based exercise program in older adults
Date of disclosure of the study information 2024/03/29
Last modified on 2024/03/29 14:48:18

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Basic information

Public title

Social implementation and effectiveness of a web-based exercise program in older adults

Acronym

Social implementation and effectiveness of a web-based exercise program in older adults

Scientific Title

Social implementation and effectiveness of a web-based exercise program in older adults

Scientific Title:Acronym

Social implementation and effectiveness of a web-based exercise program in older adults

Region

Japan


Condition

Condition

older adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Social implementation of a web-based exercise program in older adults to determine its effectiveness.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

certification of long-term care need
implementation outcomes

Key secondary outcomes

mortality
medical care cost
care cost
various diseases
mental health
frail
physical function
etc.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Web-based exercise program

Interventions/Control_2

No treatment

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

older adults at least 65 years old lived in Hachioji city with support required 2 or less

Key exclusion criteria

The person who:
1) is restricted by doctor from exercising.
2) have a history of serious illness.

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name Ryoko
Middle name
Last name Kawakami

Organization

Meiji Yasuda Life Foundation of Health and Welfare

Division name

Physical Fitness Research Institute

Zip code

192-000

Address

150 Tobuki, Hachioji, Tokyo

TEL

042-691-1163

Email

ry-kawakami@my-zaidan.or.jp


Public contact

Name of contact person

1st name Ryoko
Middle name
Last name Kawakami

Organization

Meiji Yasuda Life Foundation of Health and Welfare

Division name

Physical Fitness Research Institute

Zip code

192-0001

Address

150 Tobuki, Hachioji, Tokyo

TEL

042-691-1163

Homepage URL


Email

ry-kawakami@my-zaidan.or.jp


Sponsor or person

Institute

Physical Fitness Research Institute, Meiji Yasuda Life Foundation of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

Physical Fitness Research Institute, Meiji Yasuda Life Foundation of Health and Welfare

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Meiji Yasuda Life Foundation of Health and Welfare

Address

150 Tobuki, Hachioji, Tokyo

Tel

042-691-1163

Email

yoshida@my-zaidan.or.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

2024 Year 03 Month 29 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

2024 Year 03 Month 26 Day

Date of IRB

2024 Year 03 Month 27 Day

Anticipated trial start date

2024 Year 03 Month 29 Day

Last follow-up date

2031 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2024 Year 03 Month 29 Day

Last modified on

2024 Year 03 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061659


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name