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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011413
Receipt No. 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

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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
Email 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
Email shimada@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013364

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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