UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014880 |
|---|---|
| Receipt number | R000017305 |
| Scientific Title | Benefits of the Home-based Exercise with the Aim of Preventing Aspiration Pneumonia and Falls in the Community-dwelling Older adults. |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2016/06/14 13:32:22 |
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Basic information
Public title
Benefits of the Home-based Exercise with the Aim of Preventing Aspiration Pneumonia and Falls in the Community-dwelling Older adults.
Acronym
enefits of the Home-based Exercise with the Aim of Preventing Aspiration Pneumonia and Falls
Scientific Title
Benefits of the Home-based Exercise with the Aim of Preventing Aspiration Pneumonia and Falls in the Community-dwelling Older adults.
Scientific Title:Acronym
enefits of the Home-based Exercise with the Aim of Preventing Aspiration Pneumonia and Falls
Region
| Japan |
Condition
Condition
Frail older adults
Classification by specialty
| Geriatrics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the home-based exercise with the aim to preventing aspiration pneumonia and accidental falls improve swallowing-related functions and physical functions in the community-dwelling older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximal peak cough flow
Lip closure pressure
Incident of accidental fall
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
We instructed the participants to perform the exercise program at home at least three times a week for 6 months. The home-based exercise program had 12 elements that combined stretching, breathing exercises,balance training, muscle strengthening and dual-task training.
Interventions/Control_2
Participants in control group were advised to maintain or improve their activity in daily life and attend lectures on health.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Older adults whom Independence of self care activity.
Key exclusion criteria
Subjects with dementia or severe cognitive disorder.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Takatori |
Organization
Kio University
Division name
Faculty of Health Science
Zip code
Address
4-2-2, Umami-naka,Koryo,Kitakatsuragi-gun,Nara
TEL
0745-54-1601
k.takatori@kio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Takatori |
Organization
Kio University
Division name
Faculty of Health Science
Zip code
Address
4-2-2, Umami-naka,Koryo,Kitakatsuragi-gun,Nara
TEL
0745-54-1601
Homepage URL
k.takatori@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
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 | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://bmjopensem.bmj.com/
Number of participants that the trial has enrolled
Results
Voluntary peak cough flow in the intervention group was significantly greater than in the control group (p<0.01, d=0.5). However, lip closure force did not differ between groups. Regarding physical function, results of the Timed Up and Go Test (p<0.05, d=0.4), Chair Stand Test (p<0.01, d=0.4), maximal knee extension strength (p<0.05, d=0.4), and Sit and Reach Test (p<0.05, d=0.3) showed greater improvement in the intervention group.
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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 18 | Day |
Last modified on
| 2016 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017305
| 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 |
