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 | 2026/02/02 17:33:21 |
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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
670
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
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
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
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
Further updates to come
Publication of results
Published
Result
URL related to results and publications
https://www.rinspo.jp/journal/2010/files/27-2/292-299.pdf
Number of participants that the trial has enrolled
664
Results
Mean muscle strength (30-sec chair stand) improved from 22.3+/-5.2 to 27.1+/-5.8 times (P<0.001). Balance (one-leg stand) and flexibility (long sitting forward bending) also increased significantly across almost all categories. These results suggest that strength-building classes effectively improve physical function in the elderly and may help prevent sarcopenia.
Results date posted
| 2026 | Year | 02 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Further updates to come
Participant flow
Further updates to come
Adverse events
Further updates to come
Outcome measures
Physical function measurement,body composition measurement,health-related QOL
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033526
