UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of a simple fitness test on physical activities: Cluster randomized controlled trial
Title of the study (Brief title)	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	Susumu Sawada
Organization	National Institutes of Biomedical Innovation, Health and Nutrition
Division name	Department of Health Promotion and Exercise
Address	1-23-1 Toyama, Shinjuku, Tokyo
TEL	03-3203-5721
Email	s-sawada@nih.go.jp

Public contact
Name of contact person	Minoru Kunii
Organization	Central Sports Co.,LTD
Division name	Central Sports Institute of sports science
Address	1-21-2 Shinkawa, Chuouku, Tokyo
TEL	03-5543-1800
Homepage URL
Email	m-kunii@central.co.jp

Sponsor
Institute	National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 03 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025302