UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023138 |
|---|---|
| Receipt number | R000026674 |
| Scientific Title | The effectiveness of Locomo-call program in Ina Town |
| Date of disclosure of the study information | 2016/07/21 |
| Last modified on | 2023/12/15 14:06:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effectiveness of Locomo-call program in Ina Town
Acronym
The effectiveness of Locomo-call program in Ina Town
Scientific Title
The effectiveness of Locomo-call program in Ina Town
Scientific Title:Acronym
The effectiveness of Locomo-call program in Ina Town
Region
| Japan |
Condition
Condition
Community-dwelling elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to show the effectiveness of Locomo-call program of 3 months for improving motor function and activity in elderly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
walking speed, 5 sit to stand time, grip strength, one leg stance time, 2step test, stand up test, the 25 question geriatric locomotive function scale
Key secondary outcomes
Mascle mass, Body fat
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Home exercise of three months (muscle training and walking).
Interventions/Control_2
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
Community-dwelling elderly
Key exclusion criteria
The person who certified in long-term care insurance. The person who have a physical disability certificate.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | TOMOYUKI |
| Middle name | |
| Last name | ARAI |
Organization
Faculty of Health and Medical Care, Saitama Medical University
Division name
Department of Physical Therapy
Zip code
350-0496
Address
981 kawakado, moroyama machi, iruma gun, saitama
TEL
09047481649
arai_tm@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | TOMOYUKI |
| Middle name | |
| Last name | ARAI |
Organization
Faculty of Health and Medical Care, Saitama Medical University
Division name
Department of Physical Therapy
Zip code
350-0496
Address
981 kawakado, moroyama machi, iruma gun, saitama
TEL
09047481649
Homepage URL
arai_tm@saitama-med.ac.jp
Sponsor or person
Institute
Faculty of Health and Medical Care, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Ina Twon
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ina Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Saitama Medical University
Address
38 Morohongo, Moroyama-cho, Iruma-gun, Saitama
Tel
049-276-2143
rinri@saitama-med.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026674
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
