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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030557
Receipt No. R000034887
Scientific Title Intervention study of exercise for care prevention
Date of disclosure of the study information 2018/01/01
Last modified on 2019/06/27

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Basic information
Public title Intervention study of exercise for care prevention
Acronym Effects of the exercise for care prevention
Scientific Title Intervention study of exercise for care prevention
Scientific Title:Acronym Effects of the exercise for care prevention
Region
Japan

Condition
Condition Elderly people
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Care prevention
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Lower extremity muscle strength
Key secondary outcomes Balance function
Gait speed
Cognitive function
Quality of life

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment Behavior,custom Maneuver
Other
Interventions/Control_1 They will perform Square-stepping exercise 3 times per week for 12 weeks
Interventions/Control_2 They will perform Square-stepping exercise combined with Neuromusclar electrical stimulation3 times per week for 12 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
60 years-old <=
Age-upper limit
95 years-old >
Gender Male and Female
Key inclusion criteria Independence of gait by oneself
Key exclusion criteria 1) Contraindication of the electrical stimulation.
2) Not being able to walk more than 50m.
3) Not being able to do any exercise.
4) Contraindication of any exercise.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hiroo
Middle name
Last name Matsuse
Organization Kurume University
Division name Department of rehabilitation
Zip code 8300011
Address 67 asahi-machi, Kurume city, Fukuka, Japan
TEL 0942317568
Email matsuse_hiroh@kurume-u.ac.jp

Public contact
Name of contact person
1st name Hiroo
Middle name
Last name Matsuse
Organization Department of rehabilitation
Division name 67 asahi-machi, Kurume city, Fukuka, Japan
Zip code 8300011
Address +81942317568
TEL 0942317568
Homepage URL
Email matsuse_hiroh@kurume-u.ac.jp

Sponsor
Institute Kurume University
Institute
Department

Funding Source
Organization Department of rehabilitation, Kurume university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Review Board of Kurume University
Address 67, asahi-machi, Kurume city, Fukuoka, Japan
Tel 0942317917
Email sangaku@kurume-u.ac.jp

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 久留米大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 11 Month 10 Day
Date of IRB
2018 Year 05 Month 14 Day
Anticipated trial start date
2018 Year 05 Month 18 Day
Last follow-up date
2023 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 25 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034887

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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