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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014596
Receipt No. R000016982
Scientific Title The Effects of the Locomotion Training in Frail Elderly People utilizing day-care services:a Randomized Controlled Trial
Date of disclosure of the study information 2014/07/23
Last modified on 2015/01/03

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Basic information
Public title The Effects of the Locomotion Training in Frail Elderly People utilizing day-care services:a Randomized Controlled Trial
Acronym The Effects of the Locomotion Training in Frail Elderly People utilizing day-care services:a Randomized Controlled Trial
Scientific Title The Effects of the Locomotion Training in Frail Elderly People utilizing day-care services:a Randomized Controlled Trial
Scientific Title:Acronym The Effects of the Locomotion Training in Frail Elderly People utilizing day-care services:a Randomized Controlled Trial
Region
Japan

Condition
Condition Locomotive Syndrome
Classification by specialty
Orthopedics Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to determine
the effects of locomotion training
in frail elderly people utilizing day-care services
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical Function,Pain(Low Back Pain,Knee pain),Physical Activities,Fear of Falling,Life Space,Quality of Life
Key secondary outcomes Fall

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Training Group

Training:Locomotion training(One Leg Standing,Squat(self Training))and Physical Therapy in Day care service

Term:3Month
Interventions/Control_2 Contol Group

Training:Physical Therapy in Day care service

Term:3Month
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
97 years-old >=
Gender Male and Female
Key inclusion criteria 1)Frail Elderly People utilizing day-care services

2)Written Informed Concent
Key exclusion criteria 1)Severe pain

2)Severe cognitive impairments
(Mental Status Questionnaire 3 errors or over)
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Matsuzawa
Organization Gunma Paz College
Division name Graduate School
Zip code
Address Tonyamachi 1-7-7,takasaki,Gunma
TEL 027-365-3366
Email matsuzawa@paz.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Wataru Iriyama
Organization Gunma Paz College
Division name Graduate School
Zip code
Address Tonyamachi 1-7-7,Takasaki,Gunma
TEL 027-388-0862
Homepage URL
Email iriwata23@hotmail.co.jp

Sponsor
Institute Gunma Paz College Graduate School
Institute
Department

Funding Source
Organization Gunma Paz College Graduate School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 23 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
2014 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 09 Day
Last follow-up date
2014 Year 12 Month 12 Day
Date of closure to data entry
2014 Year 12 Month 22 Day
Date trial data considered complete
2014 Year 12 Month 22 Day
Date analysis concluded
2014 Year 12 Month 22 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 19 Day
Last modified on
2015 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016982

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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