UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037559 |
|---|---|
| Receipt number | R000042824 |
| Scientific Title | single group assignment,time series designed trial |
| Date of disclosure of the study information | 2019/08/15 |
| Last modified on | 2023/02/06 13:18:30 |
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Basic information
Public title
Effects of long-term comprehensive muscle strength training for middle aged and elderly people.
Acronym
Follow class
Scientific Title
single group assignment,time series designed trial
Scientific Title:Acronym
Follow class
Region
| Japan |
Condition
Condition
middle aged and elderly people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects on physical function and body composition such as muscle strength and health related QOL for long-term strength training and stretch instruction in middle and old aged people.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical function measurement,body composition measurement,health related quality of life
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
We will hold a follow-up class for improving muscle strength once every two months for community middle-aged and elderly people, and encourage 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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The participant who continued to attend during the classroom implementation period.
The participant who were able to evaluate at the beginning and end of the classroom.
The participant who obtained written consent by the person's free intention after sufficient explanation after participating in this study after sufficient understanding.
Key exclusion criteria
The participant who continued difficulty of classroom participation by progress of some disease.
The participant who was judged by class operation doctor to cancel the class.
In addition,the participant judged inappropriate by the classroom operation doctor.
Target sample size
100
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
2168511
Address
2-16-1,Sugao,Miyamae-ku,Kawasaki-shi
TEL
044-977-8111
fujiya-1487@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | RYOTA |
| Middle name | |
| Last name | MUROI |
Organization
St.Marianna University School of Medicine
Division name
Department of sports Medicine
Zip code
2168511
Address
2-16-1,Sugao,Miyamae-ku,Kawasaki-shi
TEL
044-977-8111
Homepage URL
ryota.muroi@marianna-u.ac.jp
Sponsor or person
Institute
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
Bioethics Review Committee,St.Marianna University School of Medicine
Address
2-16-1,Sugao,Miyamae-ku,Kawasaki-shi
Tel
044-977-8111
k-sienbu.mail@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
| 2019 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
67
Results
The present evaluation showed that training guidance provided once every two months improved or maintained lower limb muscle strength and flexibility. However, it suggested that balance ability decreased due to age-related changes even if guidance is given at this frequency.
Results date posted
| 2023 | Year | 02 | Month | 06 | Day |
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
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 31 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042824
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
