UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014596 |
|---|---|
| Receipt number | 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 19:36:21 |
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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
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
iriwata23@hotmail.co.jp
Sponsor or person
Institute
Gunma Paz College Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016982
| 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 |
