UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023191 |
|---|---|
| Receipt number | R000026701 |
| Scientific Title | The effects of the intervention to the domestic role for the frail elderly |
| Date of disclosure of the study information | 2016/08/15 |
| Last modified on | 2019/12/27 11:28:39 |
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Basic information
Public title
The effects of the intervention to the domestic role for the frail elderly
Acronym
The effects of the intervention to the domestic role for the frail elderly
Scientific Title
The effects of the intervention to the domestic role for the frail elderly
Scientific Title:Acronym
The effects of the intervention to the domestic role for the frail elderly
Region
| Japan |
Condition
Condition
Frail elderly people
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of interventions by the domestic role for frail elderly people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
the number of steps taken before and
after intervention(6weeks,12weeks)
Key secondary outcomes
grip strength
Timed up & go test
Short Physical Performance Battery
muscle strength of knee extension
Geriatric Depression Scale 5(GDS5)
Modified Falls Efficacy Scale(MFES)
Functional Independence Measure(FIM)
Life-space Assessment(LSA)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Usual care and Domestic role
Interventions/Control_2
Usual care and Exercise
Interventions/Control_3
Usual care
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
Frail elderly people at a day care center
Certified as requiring support level 2 or long-term care level 1 or 2 in their long-term care insurance
Key exclusion criteria
No self-reliance of indoor walking
MMSE<24
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Ando |
Organization
Aino university
Division name
Department of Physical Therapy , Faculty of Health Science
Zip code
567-0122
Address
4-5-4, Higashioda Ibaraki city Osaka
TEL
072-627-1711
s-ando@pt-u.aino.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Prefecture University
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
583-0855
Address
3-7-30,Habikino,Habikino city
TEL
0729-950-2111
Homepage URL
yumi@rehab.ssakafu-u.ac.jp
Sponsor or person
Institute
Osaka Prefecture University
Institute
Department
Personal name
Funding Source
Organization
Osaka Prefecture University
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
Osaka Prefecture University
Address
3-7-30 Habikino, Habikino-shi, Osaka
Tel
0726271711
yumi@rehab.ssakafu-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
特別養護老人ホーム高寿園デイサービスセンター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
https://journals.humankinetics.com/view/journals/japa/japa-overview.xml
Publication of results
Published
Result
URL related to results and publications
https://journals.humankinetics.com/view/journals/japa/japa-overview.xml
Number of participants that the trial has enrolled
36
Results
Over the 12 weeks, the number of steps in the CDR group increased incrementally. However, the step count in the HE group did not change significantly, and the step count in the CON group decreased gradually. The rates of change in each group at six and 12 weeks were 22.8% and 25.3% for the CDR group, -3.7% and 0.4% for the HE group, and -2.8% and -21.9% for the CON group.
Results date posted
| 2019 | Year | 12 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were recruited from three centers, of which two are in Osaka prefecture and the other is in Shiga prefecture. Inclusion criteria were as follows: aged 65 years or older, able to walk indoors by themselves (regardless of the use of auxiliary tools), able to understand the purpose of the study, and providing consent. Exclusion criteria were as follows: pacemaker implantation and Mini-Mental State Examination (MMSE) score under 24.
Participant flow
Participants meeting the criteria were assigned to three groups, namely custom-made daily routine intervention (CDR), home-based exercise intervention (HE), and control (CON) according to their days of attending the day care center. Based on the results of a draw performed by a person uninvolved in the study, we defined the CDR group as those who attended the center on Wednesday or Saturday, the HE group as those who attended on Tuesday or Friday, and the CON group as those who attended on the remaining days. If there were participants who attended on multiple days, the independent person allocated them randomly.
Adverse events
One participant in the CDR group experienced irritation on her back while wearing the accelerometer. Although there were no abnormal findings on the skin, we followed the request of the participant and withdrew her from the study. One participant in the CON group experienced irritation on the wrist because of the accelerometer. When the participant removed the band and briefly massaged the area the irritation stopped, and she immediately placed the band back on her wrist.
Outcome measures
For the objective measurement of number of steps, the primary outcome, we used a wrist-worn three-axis accelerometer (UP2, Jawbone Inc., San Francisco, CA) and measured the number of steps in 24 hours for eight days. As secondary incidental outcomes, we evaluated activities of daily living (ADL) and physical functions. For ADL we used the Functional Independence Measure (FIM; Granger, Hamilton, Linacre, Heinemann, & Wright, 1993). For the physical function evaluation, we performed knee extension muscle strength evaluations and the Timed Up and Go (TUG) test.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 05 | 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 | 15 | Day |
Last modified on
| 2019 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026701
| 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 |
