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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011418
Receipt No. 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

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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
Email 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
Email noventurenoglory@gmail.com

Sponsor
Institute Yokohama City University Medical Center, Department of Rehabilitation Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013370

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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