UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047741 |
|---|---|
| Receipt number | R000054427 |
| Scientific Title | Effects of participation in care prevention class on motor function in community-dwelling elderly people |
| Date of disclosure of the study information | 2022/05/12 |
| Last modified on | 2022/11/11 09:53:41 |
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Basic information
Public title
Effects of participation in care prevention class on motor function in community-dwelling elderly people
Acronym
Effects of participation in care prevention class on motor function in community-dwelling elderly people
Scientific Title
Effects of participation in care prevention class on motor function in community-dwelling elderly people
Scientific Title:Acronym
Effects of participation in care prevention class on motor function in community-dwelling elderly people
Region
| Japan |
Condition
Condition
Elderly people
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of participation in care prevention class on motor function, especially in postural control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postural disturbance, Functional reach, Gait speed, Stride length, Gait variability, Turning
Key secondary outcomes
Activities-related balance confidence scale, Qualities of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Balance training
Interventions/Control_2
Education for care prevention,
Recreation
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants can keep going to a care prevention class, standing and sitting independently.
Key exclusion criteria
Severe cognitive impairments, People cannot keep standing or sitting
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Hasegawa |
Organization
Hokkaido University
Division name
Department of Rehabilitation Science, Faculty of Health Sciences
Zip code
0600812
Address
Kita 12 Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
0117063531
n_hasegawa@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Hasegawa |
Organization
Hokkaido University
Division name
Department of Rehabilitation Science, Faculty of Health Sciences
Zip code
0600812
Address
Kita 12 Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
0117063531
Homepage URL
n_hasegawa@hs.hokudai.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Science, Faculty of Health Sciences, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Hokkaido Univerisy
Address
Kita12 Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan
Tel
0117063531
n_hasegawa@hs.hokudai.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
北海道大学，介護予防センター旭ヶ丘
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | 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
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 12 | Day |
Last modified on
| 2022 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054427
| 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 |
