UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030557 |
|---|---|
| Receipt number | R000034887 |
| Scientific Title | Intervention study of exercise for care prevention |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2021/03/22 14:57:16 |
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Basic information
Public title
Intervention study of exercise for care prevention
Acronym
Effects of the exercise for care prevention
Scientific Title
Intervention study of exercise for care prevention
Scientific Title:Acronym
Effects of the exercise for care prevention
Region
| Japan |
Condition
Condition
Elderly people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Care prevention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Lower extremity muscle strength
Key secondary outcomes
Balance function
Gait speed
Cognitive function
Quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
| Other |
Interventions/Control_1
They will perform Square-stepping exercise 3 times per week for 12 weeks
Interventions/Control_2
They will perform Square-stepping exercise combined with Neuromusclar electrical stimulation3 times per week for 12 weeks
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Independence of gait by oneself
Key exclusion criteria
1) Contraindication of the electrical stimulation.
2) Not being able to walk more than 50m.
3) Not being able to do any exercise.
4) Contraindication of any exercise.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Matsuse |
Organization
Kurume University
Division name
Department of rehabilitation
Zip code
8300011
Address
67 asahi-machi, Kurume city, Fukuka, Japan
TEL
0942317568
matsuse_hiroh@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroo |
| Middle name | |
| Last name | Matsuse |
Organization
Department of rehabilitation
Division name
67 asahi-machi, Kurume city, Fukuka, Japan
Zip code
8300011
Address
+81942317568
TEL
0942317568
Homepage URL
matsuse_hiroh@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Department of rehabilitation, Kurume university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Kurume University
Address
67, asahi-machi, Kurume city, Fukuoka, Japan
Tel
0942317917
sangaku@kurume-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
久留米大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 04 | 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
| 2017 | Year | 12 | Month | 25 | Day |
Last modified on
| 2021 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034887
| 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 |
