UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021937
Receipt number R000025302
Scientific Title The influence of a simple fitness test on physical activities: Cluster randomized controlled trial
Date of disclosure of the study information 2016/04/16
Last modified on 2016/11/05 11:50:52

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Basic information

Public title

The influence of a simple fitness test on physical activities: Cluster randomized controlled trial

Acronym

The influence of a simple fitness test on physical activities: Cluster randomized controlled trial

Scientific Title

The influence of a simple fitness test on physical activities: Cluster randomized controlled trial

Scientific Title:Acronym

The influence of a simple fitness test on physical activities: Cluster randomized controlled trial

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to investigate the influence of a simple fitness test as a trigger for increasing physical activity among workers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Increase of physical activities

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Recommend various exercise sports and climbing stairs up/down, to subjects who are not able to stand up from a chair on a single leg

Interventions/Control_2

Health check-up at the time of the measurement before intervention

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

20 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy adults

Key exclusion criteria

No serious underlying diseases

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Susumu Sawada

Organization

National Institutes of Biomedical Innovation, Health and Nutrition

Division name

Department of Health Promotion and Exercise

Zip code


Address

1-23-1 Toyama, Shinjuku, Tokyo

TEL

03-3203-5721

Email

s-sawada@nih.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Minoru Kunii

Organization

Central Sports Co.,LTD

Division name

Central Sports Institute of sports science

Zip code


Address

1-21-2 Shinkawa, Chuouku, Tokyo

TEL

03-5543-1800

Homepage URL


Email

m-kunii@central.co.jp


Sponsor or person

Institute

National Institutes of Biomedical Innovation, Health and Nutrition

Institute

Department

Personal name



Funding Source

Organization

Self-funding

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


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

2016 Year 04 Month 16 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

Terminated

Date of protocol fixation

2016 Year 03 Month 17 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 17 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

2016 Year 04 Month 16 Day

Last modified on

2016 Year 11 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025302


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name