UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021071 |
|---|---|
| Receipt number | R000024307 |
| Scientific Title | The Effect of "Exercise as Part of Your Daily Life" on Mobility in Community Dwelling Elderly: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2016/02/19 |
| Last modified on | 2022/08/25 23:48:16 |
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Basic information
Public title
The Effect of "Exercise as Part of Your Daily Life" on Mobility in Community Dwelling Elderly: A Randomized Controlled Trial
Acronym
The Effect of "Exercise as Part of Your Daily Life" on Mobility in Community Dwelling Elderly: A Randomized Controlled Trial
Scientific Title
The Effect of "Exercise as Part of Your Daily Life" on Mobility in Community Dwelling Elderly: A Randomized Controlled Trial
Scientific Title:Acronym
The Effect of "Exercise as Part of Your Daily Life" on Mobility in Community Dwelling Elderly: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
65 years old or older community dwelling adults
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether "exercise as part of your daily life" improves the mobility of community dwelling older people
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Before and after difference of dual task Timed Up and Go Test (TUG), adjusted with age, gender, BMI, and baseline dual task TUG
Key secondary outcomes
Single task TUG, single limb stance time, falls, Fall Efficacy Scale (Japanese version)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Physical activity program focus on "exercise as part of your daily life"
Interventions/Control_2
No intervention
The control group will have a lecture about fall prevention in general.
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
Participants of the health educational program in Nishigo village.
Key exclusion criteria
Not applicable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Soeno |
Organization
Shirakawa Kosei General Hospital
Division name
General Internal Medicine
Zip code
961-0005
Address
2-1, Kamiyajiro, Toyochi, Shirakawa
TEL
0248-22-2211
shoko.soeno@gmail.com
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Soeno |
Organization
Shirakawa Kosei General Hospital
Division name
General Internal Medicine
Zip code
961-0005
Address
2-1, Kamiyajiro, Toyochi, Shirakawa
TEL
0248-22-2211
Homepage URL
shoko.soeno@gmail.com
Sponsor or person
Institute
Shirakawa Kosei General Hospital
Institute
Department
Personal name
Funding Source
Organization
not applicable
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shirakawa Kosei General Hospital
Address
2-1, Kamiyajiro, Toyochi, Shirakawa
Tel
0248-22-2211
shoko.soeno@gmail.com
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 | 02 | Month | 19 | 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
40
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
Terminated
Date of protocol fixation
| 2016 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 01 | 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 | 02 | Month | 17 | Day |
Last modified on
| 2022 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024307
