UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008152 |
|---|---|
| Receipt number | R000009576 |
| Scientific Title | Effects of walking exercise used the stride assistance system on physical performances in the frail older adults: randomized control trial |
| Date of disclosure of the study information | 2012/06/15 |
| Last modified on | 2014/01/15 09:30:30 |
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Basic information
Public title
Effects of walking exercise used the stride assistance system on physical performances in the frail older adults: randomized control trial
Acronym
Effects of walking exercise used the stride assistance system on physical performances in the frail older adults: randomized control trial
Scientific Title
Effects of walking exercise used the stride assistance system on physical performances in the frail older adults: randomized control trial
Scientific Title:Acronym
Effects of walking exercise used the stride assistance system on physical performances in the frail older adults: randomized control trial
Region
| Japan |
Condition
Condition
frailty
Classification by specialty
| Geriatrics | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of walking exercise used the stride assistance system on physical performances.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait function: speed, stride, cadence, energy efficiency
Physical activity pattern: Accelerometer, GPS, PASE
Key secondary outcomes
Physical functions: muscle strength, balance
Cognitive functions: MMSE, TMT
Brain volume: MRI
Body composition: DXA, BIA
Functional capacity: IADL, Tokyo Metropolitan Institute of Gerontology Index of Competence
QOL: SF-12
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Gait and assist group: Perform walking exercise used the stride assistance system for 90 min/session (twice a week in the first half and once a week in the second half of exercise session, total 48 times per year)
Interventions/Control_2
Only gait group: Perform walking exercise without the stride assistance system for 90 min/session (twice a week in the first half and once a week in the second half of exercise session, total 48 times per year)
Interventions/Control_3
Educational group: Lecture about disease and health (3 times per year)
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
1) Elderly people, aged 65 over and living in Obu city, having health check from Aug in 2011 to Feb in 2012.
2) Having physical frailty
3) Being agreed with participation in the study
Key exclusion criteria
1) Having serious or unstable illnesses
2) History of stroke or Parkinson's disease
3) MMSE score < 18
4) Having difficulty in gait
5) Participating other projects
6) Needing long-term care
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suzuki Takao |
Organization
National Center for Geriatrics and Gerontology
Division name
Research Institute
Zip code
Address
35 Gengo, Morioka-machi, Obu, Aichi, 474-8511, Japan
TEL
0562-46-2311
suzutaka@ncgg.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shimada Hiroyuki |
Organization
National Center for Geriatrics and Gerontology
Division name
Department for Research and Development to Support Independent Life of Elderly
Zip code
Address
35 Gengo, Morioka-machi, Obu, Aichi, 474-8511, Japan
TEL
0562-46-2311
Homepage URL
shimada@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare (Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Honda R&D Co., Ltd.
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
リソラ大府（愛知県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 15 | 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
| 2012 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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
| 2012 | Year | 06 | Month | 12 | Day |
Last modified on
| 2014 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009576
| 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 |
