UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establishment of HOspital based exercise Program for Prevention of lifestyle related diseases
Title of the study (Brief title)	E-HOPP study
Region	Japan

Condition
Condition	Lifestyle related disease
Classification by specialty	Medicine in general Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Establishment of hospital based exercise program for prevention of lifestyle related disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety and long-term maintenance of exercise program
Key secondary outcomes	Physical fitness Physical activity Prevention of lifestyle related disease Quality of life

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects without severe chronic diseases
Key exclusion criteria	Subjects who can not afford to participate exercise program Pregnant women Subjects who already adopt a routine of enough regular exercise
Target sample size	999

Research contact person
Name of lead principal investigator	Koichiro Azuma
Organization	Keio University
Division name	Institute for Integrated Sports Medicine, School of Medicine
Address	35 Shinanomachi, Shinjuku, Tokyo 160-8582
TEL
Email

Public contact
Name of contact person
Organization	Keio University
Division name	Institute for Integrated Sports Medicine, School of Medicine
Address	35 Shinanomachi, Shinjuku, Tokyo 160-8582
TEL
Homepage URL
Email

Sponsor
Institute	Institute for Integrated Sports Medicine, School of Medicine, Keio University
Institute
Department

Funding Source
Organization	Institute for Integrated Sports Medicine, School of Medicine, Keio University
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 07 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 11 Month 02 Day
Anticipated trial start date	2013 Year 07 Month 01 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	Evaluation of safety, adoption and effect of exercise program regularly

Management information
Registered date	2013 Year 06 Month 27 Day
Last modified on	2018 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012940