UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029334
Receipt number 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 2021/08/12 14:24:44

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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 HIROTO
Middle name
Last name FUJIYA

Organization

St. Marianna University School of Medicine

Division name

Department of Sports Medicine

Zip code

216-8511

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 FUMIKO
Middle name
Last name TERAWAKI

Organization

St. Marianna University School of Medicine

Division name

Department of Sports Medicine

Zip code

216-8511

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki

TEL

044-977-8111

Homepage URL


Email

f.terra@marianna-u.ac.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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

St. Marianna University School of Medicine

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki

Tel

+81449778111

Email

kanaka@marianna-u.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

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

Enrolling by invitation

Date of protocol fixation

2007 Year 04 Month 01 Day

Date of IRB

2012 Year 05 Month 21 Day

Anticipated trial start date

2017 Year 09 Month 29 Day

Last follow-up date

2020 Year 12 Month 31 Day

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

2021 Year 08 Month 12 Day



Link to view the page

Value
https://center6.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