UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027786 |
|---|---|
| Receipt number | R000031841 |
| Scientific Title | Quantitative study of health promotion effect by exercise equipment. Strength and QOL effect of frail elderly using hybrid training. |
| Date of disclosure of the study information | 2017/06/16 |
| Last modified on | 2019/06/04 12:22:53 |
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Basic information
Public title
Quantitative study of health promotion effect by exercise equipment. Strength and QOL effect of frail elderly using hybrid training.
Acronym
Development of exercise equipment for frail elderly
Scientific Title
Quantitative study of health promotion effect by exercise equipment. Strength and QOL effect of frail elderly using hybrid training.
Scientific Title:Acronym
Development of exercise equipment for frail elderly
Region
| Japan |
Condition
Condition
frail elderly
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose is to develop exercise equipment for frail elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle strength
Key secondary outcomes
QOL
muscle thickness
abiluty of gait
ability of balance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical stimulation
Interventions/Control_2
No electrical stimulation
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly people without hindrance to exercise
Key exclusion criteria
Cognitive disorders
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yoshio TAKANO |
Organization
International university of health and welfare
Division name
school of health science, fukuoka
Zip code
Address
137-1 enokuzu Okawa Fukuoka
TEL
0944-89-2000
y-takano@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yoshio TAKANO |
Organization
International university of health and welfare
Division name
school of health science, fukuoka
Zip code
Address
137-1 enokuzu Okawa Fukuoka
TEL
0944-89-2000
Homepage URL
y-takano@iuhw.ac.jp
Sponsor or person
Institute
school of health science, fukuoka
Institute
Department
Personal name
Funding Source
Organization
Panasonic Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | 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
| 2017 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 16 | Day |
Last modified on
| 2019 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031841
