UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054055 |
|---|---|
| Receipt number | R000061719 |
| Scientific Title | Research on the development and feasibility of care-prevention exercises for community-dwelling older people and their effectiveness in improving physical function |
| Date of disclosure of the study information | 2024/04/05 |
| Last modified on | 2024/04/04 09:57:15 |
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Basic information
Public title
Research on the development and feasibility of care-prevention exercises with locally specific music for community-dwelling older people
Acronym
Research on the development of care-prevention exercises with locally specific-music
Scientific Title
Research on the development and feasibility of care-prevention exercises for community-dwelling older people and their effectiveness in improving physical function
Scientific Title:Acronym
the development and feasibility of care-prevention exercises and their effectiveness
Region
| Japan |
Condition
Condition
fit community-dwelling older adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the feasibility of exercise and the effect on physical function improvement of a care-prevention exercise using original local music, which we developed in collaboration with residents.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Continuation rate of exercise
Key secondary outcomes
accidents of falling, pain during exercises, ease of performing exercises, walking speed, sit-to-stand test, knee extension strength, standing on one leg, and body composition (muscle mass, fat mass)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The developed exercises will be introduced at the community meeting place, where people meet once a week and where exercise is regularly practiced. After informing the participants about the exercises and the precautions to be taken to ensure their safe implementation, they are asked to watch a video and a leaflet and perform the developed exercises once a week for three months, in addition to the exercises they already do.
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
Community-dwelling older adults who are already participating in the commuting places
Key exclusion criteria
# Persons who have been certified as requiring nursing care.
# Those with a history of neurological disease (e.g. stroke, Parkinson's disease) that affects balance function.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Misu |
Organization
Konan Women's University
Division name
Faculty of Nursing and Rehabilitation
Zip code
658-0001
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
TEL
0784133584
s-misu@konan-wu.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Misu |
Organization
Konan Women's University
Division name
Faculty of Nursing and Rehabilitation
Zip code
658-0001
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe
TEL
0784133584
Homepage URL
s-misu@konan-wu.ac.jp
Sponsor or person
Institute
Konan Women's University
Institute
Department
Personal name
Shogo Misu
Funding Source
Organization
Konan Women's University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Konan Women's University Research Ethics Committee
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe,
Tel
078-413-3972
gakuken@konan-wu.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
| 2024 | Year | 04 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061719
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
