UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019711
Receipt number R000021479
Scientific Title Health Promotion in Elderly in Moroyama
Date of disclosure of the study information 2015/12/01
Last modified on 2021/03/18 13:10:59

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Basic information

Public title

Health Promotion in Elderly in Moroyama

Acronym

Health Promotion in Elderly in Moroyama

Scientific Title

Health Promotion in Elderly in Moroyama

Scientific Title:Acronym

Health Promotion in Elderly in Moroyama

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

we will reveal the effect of guidance of exercise and nutrition.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

muscle volume, body composition, amount of activity

Key secondary outcomes



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

exercise

Interventions/Control_2

no exercise

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

50 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

who has no medical history.
who has some medical history but who's doctor allows to exercise.

Key exclusion criteria

who is not allowed to exercise.
who can not exercise.

Target sample size

75


Research contact person

Name of lead principal investigator

1st name Emi
Middle name
Last name Suwa

Organization

Saitama Medical University

Division name

community health science center

Zip code

350-0495

Address

38 morohongou, moroyama machi, iruma gun, saitama

TEL

049-276-1168

Email

esuwa@saitama-med.ec.jp


Public contact

Name of contact person

1st name Emi
Middle name
Last name Suwa

Organization

Saitama Medical University

Division name

community health science center

Zip code

350-0495

Address

38 morohongou, moroyama machi, iruma gun, saitama

TEL

049-276-1168

Homepage URL


Email

esuwa@saitama-med.ec.jp


Sponsor or person

Institute

Saitama Medical University community health science center

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University community health science center

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

Ethical Committee of Saitama Medical University

Address

38 morohongou, moroyama machi, iruma gun, saitama

Tel

0492762143

Email

rinri@saitama-med.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

2015 Year 12 Month 01 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

2015 Year 11 Month 18 Day

Date of IRB

2015 Year 07 Month 20 Day

Anticipated trial start date

2015 Year 11 Month 01 Day

Last follow-up date

2018 Year 12 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 11 Month 09 Day

Last modified on

2021 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021479


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name