UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051214 |
|---|---|
| Receipt number | R000055756 |
| Scientific Title | Research on the Effectiveness of Minokamo's Frail Prevention Exercises |
| Date of disclosure of the study information | 2023/05/31 |
| Last modified on | 2023/05/31 17:54:37 |
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Basic information
Public title
Research on the Effectiveness of Minokamo's Frail Prevention Exercises
Acronym
Research on the Effectiveness of Minokamo's Frail Prevention Exercises
Scientific Title
Research on the Effectiveness of Minokamo's Frail Prevention Exercises
Scientific Title:Acronym
Research on the Effectiveness of Minokamo's Frail Prevention Exercises
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effectiveness of the "Minokamo Flail Prevention Exercise" created based on a collaborative agreement with Minokamo City.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following items are performed at first and after 2 weeks
Grip strength
Short physical performance battery
Functional reach test
Timed up and go test
Seated stepping test
Ten-step test
Long seated forward bending test
Muscle thickness
Skeletal muscle mass
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
physical exercises
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
The subjects were determined to be frail and aged 65 years or older who (1) had not experienced Minokamo exercise, (2) were not certified as requiring nursing care or support, (3) were independent in basic ADLs, and (4) did not have cardiovascular, respiratory, neurological, or orthopedic diseases that would limit their ability to perform physical exercise.
Key exclusion criteria
Persons with cognitive impairment that interferes with daily life
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Tomiyama |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai City, Aichi Prefecture
TEL
052-601-6000
tomiyama@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Tomiyama |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai City, Aichi Prefecture
TEL
052-601-6000
Homepage URL
tomiyama@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
Seijoh University
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
Seijoh University
Address
2-172 Fukinodai, Tokai City, Aichi Prefecture
Tel
052-601-6000
tomiyama@seijoh-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
| 2023 | Year | 05 | Month | 31 | 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
7
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
| 2022 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055756
