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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029334
Receipt No. R000033526
Scientific Title The effect of the comprehensive muscular strength training for the community elderly.
Date of disclosure of the study information 2017/09/29
Last modified on 2017/09/28

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Basic information
Public title The effect of the comprehensive muscular strength training for the community elderly.
Acronym Marianna Strength Improvement Class
Scientific Title The effect of the comprehensive muscular strength training for the community elderly.
Scientific Title:Acronym Marianna Strength Improvement Class
Region
Japan

Condition
Condition the community elderly
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For elderly people resident in an area, we conduct the Muscular strength training and perform the effect inspection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The physical function evaluation measurement
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 The community elderly people were participated in three-month muscle strength class in addition to promote home training.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) The participant who it continues during
class enforcement period, and can take lectures.
2) The participant that an evaluation is possible at the start and the end of this class.
3) The participant that a document agreement by the free will of the person was provided after enough understanding after having received enough explanation on participating of this study.
Key exclusion criteria 1)The participant who came to have difficulty with this class continuation by the progression of some kind of diseases.
2) The participant whom it was judged a doctor to quit it during attendance.
3) In addition, the participant whom it was judged a doctor to be inappropriate.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HIROTO FUJIYA
Organization St. Marianna University School of Medicine
Division name Department of Sports Medicine
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL 044-977-8111
Email sports@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name TERAWAKI FUMIKO
Organization St. Marianna University School of Medicine
Division name Department of Sports Medicine
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL 044-977-8111
Homepage URL
Email f.terra@marianna-u.ac.jp

Sponsor
Institute Department of Sports Medicine, St. Marianna University School of Medicine.
Institute
Department

Funding Source
Organization Department of Sports Medicine, St. Marianna University School of Medicine.
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
2017 Year 09 Month 29 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 Preinitiation
Date of protocol fixation
2007 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 29 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
2017 Year 09 Month 28 Day
Last modified on
2017 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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