UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017922 |
|---|---|
| Receipt number | R000020776 |
| Scientific Title | Construction of new care preventive intervention program by developing comprehensive exercise supportive system |
| Date of disclosure of the study information | 2015/06/16 |
| Last modified on | 2017/06/19 18:25:42 |
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Basic information
Public title
Construction of new care preventive intervention program by developing comprehensive exercise supportive system
Acronym
Effect of comprehensive exercise supportive system for care prevention
Scientific Title
Construction of new care preventive intervention program by developing comprehensive exercise supportive system
Scientific Title:Acronym
Effect of comprehensive exercise supportive system for care prevention
Region
| Japan |
Condition
Condition
Older people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of comprehensive exercise support system for care prevention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frenchay Activities Index
Key secondary outcomes
muscle strength, muscle mass, physical activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom | Other |
Interventions/Control_1
muscle strength trainging
Interventions/Control_2
Increase of physical activity
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 people attending care facility
Key exclusion criteria
Dementia
Severe heart disease
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koutatsu Nagai |
Organization
Hyogo University of health sciences
Division name
Facalty of Rehabilitation
Zip code
Address
6-3-1 minatojima tyu-o-ku, kobe
TEL
078-304-3047
nagai-k@huhs.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koutatsu Nagai |
Organization
Hyogo University of health sciences
Division name
Facalty of Rehabilitation
Zip code
Address
6-3-1 minatojima tyu-o-ku, kobe
TEL
078-304-3047
Homepage URL
nagai-k@huhs.ac.jp
Sponsor or person
Institute
Hyogo University of health sciences
Institute
Department
Personal name
Funding Source
Organization
Hyogo University of health sciences
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
Address
Tel
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
| 2015 | Year | 06 | Month | 16 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2017 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020776
