UMIN-CTR Clinical Trial

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
Institute	Saitama Medical University community health science center
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021479