UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Resistance training of swallowing muscles for the home bound elderly with dysphagia: a cluster randomized controlled trial
Title of the study (Brief title)	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	Hidetaka Wakabayashi
Organization	Yokohama City University Medical Center
Division name	Department of Rehabilitation Medicine
Address	4-57 Urafune-chou, Minami ward, Yokohama city
TEL	045-261-5656
Email	noventurenoglory@gmail.com

Public contact
Name of contact person	Hidetaka Wakabayashi
Organization	Yokohama City University Medical Center
Division name	Department of Rehabilitation Medicine
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000013370