UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011413 |
|---|---|
| Receipt number | R000013364 |
| Scientific Title | Effects of walking exercise used the stride assistance system on physical function: cluster randomized control trial in frail older adults |
| Date of disclosure of the study information | 2013/08/07 |
| Last modified on | 2014/08/14 14:06:22 |
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Basic information
Public title
Effects of walking exercise used the stride assistance system on physical function: cluster randomized control trial in frail older adults
Acronym
Effects of walking exercise used the stride assistance system on physical function: cluster randomized control trial in frail older adults
Scientific Title
Effects of walking exercise used the stride assistance system on physical function: cluster randomized control trial in frail older adults
Scientific Title:Acronym
Effects of walking exercise used the stride assistance system on physical function: cluster randomized control trial in frail older adults
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 function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Gait function: speed, stability
Physical functions: muscle strength, balance
Key secondary outcomes
Physical activity pattern: Accelerometer
Functional capacity: IADL, TMIG-IC
QOL: EQ5D
Depression: GDS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Perform walking exercise used the stride assistance system for 60 min / week for 20 weeks and conventional physical therapy
Interventions/Control_2
Control group: Conventional physical therapy included muscle strength, balance retraining, and gait exercises for 20 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1: Users of day-care services
2: 65 years or older
3: Have a certification of the long-term care insurance (support level or care level 2)
4: Being agreed with participation in the study
Key exclusion criteria
1: Have serious or unstable illnesses
2: Have severe cognitive impairment
3: Have difficulty in gait
4: Participant in other studies
Target sample size
200
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 of functioning activation
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
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Honda R&D Co., Ltd.
Tsukui Co.
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
株式会社ツクイ（全国20事業所）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 07 | 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
| 2013 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 07 | Day |
Last modified on
| 2014 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013364
