UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011418 |
|---|---|
| Receipt number | R000013370 |
| Scientific Title | Resistance training of swallowing muscles for the home bound elderly with dysphagia: a cluster randomized controlled trial |
| Date of disclosure of the study information | 2013/08/10 |
| Last modified on | 2017/08/11 09:03:21 |
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Basic information
Public title
Resistance training of swallowing muscles for the home bound elderly with dysphagia: a cluster randomized controlled trial
Acronym
Resistance training of swallowing muscles for the home bound elderly with dysphagia: a cluster randomized controlled trial
Scientific Title
Resistance training of swallowing muscles for the home bound elderly with dysphagia: a cluster randomized controlled trial
Scientific Title:Acronym
Resistance training of swallowing muscles for the home bound elderly with dysphagia: a cluster randomized controlled trial
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of resistance training of swallowing muscles for the home bound elderly with dysphagia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Improvement of dysphagia (EAT-10 score less than 3 point)
Key secondary outcomes
swallowing muscles strength, nutrition status, admission due to pneumonia, all cause admission and mortality
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Lingual exercise and head flexion exercise with resistance by hand on forehead : once=10 seconds, 1 set=10 times, 2 set/day, 3 times/week, for 3 months
nutrition counseling: once
Interventions/Control_2
nutrition counseling: once
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
(1)using day-care or day-service facilities
(2)aged 65 years and older
(3)EAT-10 score was 3 points and above
(4)able to answer the questionnaire
(5)obtained written informed consent
Key exclusion criteria
(1)EAT-10 score was less than 3 points
(2)unable to answer the questionnaire due to cognitive impairment
(3)unable to perform resistance training due to complications such as angina and myocardiac infarction
(4)judged inappropriate to participate by doctors
Target sample size
126
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetaka Wakabayashi |
Organization
Yokohama City University Medical Center
Division name
Department of Rehabilitation Medicine
Zip code
Address
4-57 Urafune-chou, Minami ward, Yokohama city
TEL
045-261-5656
noventurenoglory@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetaka Wakabayashi |
Organization
Yokohama City University Medical Center
Division name
Department of Rehabilitation Medicine
Zip code
Address
4-57 Urafune-chou, Minami ward, Yokohama city
TEL
045-261-5656
Homepage URL
noventurenoglory@gmail.com
Sponsor or person
Institute
Yokohama City University Medical Center, Department of Rehabilitation Medicine
Institute
Department
Personal name
Funding Source
Organization
Comprehensive Research on Aging and Health
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
鶴巻温泉病院（神奈川県）、デイサービスおたふく郡元（鹿児島県）、あいの里クリニック（岡山県）、横浜市総合保健医療センター（神奈川県）、総合南東北病院（福島県）、リハパーク舞岡（神奈川県）、プラチナヴィラ青葉台（神奈川県）、スカイ（神奈川県）、マイライフ尾根道（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 10 | 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
| 2013 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 08 | Day |
Last modified on
| 2017 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013370
| 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 |
