UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial to verify the effectiveness of comprehensive swallowing training method for dysphagia
Title of the study (Brief title)	Randomized controlled trial to verify the effectiveness of comprehensive swallowing training method for dysphagia
Region	Japan

Condition
Condition	dysphagia
Classification by specialty	Geriatrics Oto-rhino-laryngology Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verify that there is an additional effect of improvement of swallowing function compared with training of each alone by training the oropharyngeal and respiratory training for patients with mild to moderate swallowing disorders .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement degree of MASA (Mann Assessment of Swallowing Ability) score before and after training
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	4 weeks training of oral and oropharynx (tongue motion training and suprahyoid muscles training)
Interventions/Control_2	4 weeks breathing training (Huffing and Expiratory Muscle Strength Training)
Interventions/Control_3	4 weeks training of oral, oropharynx and breathing training (tongue motion training, suprahyoid muscles training, Huffing and Expiratory Muscle Strength Training)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Mild to moderate dysphagia (MASA score 139 to 177 points)
Key exclusion criteria	(1) Dysphagia due to organic causes (ex.; Head and neck cancer, head and neck radiotherapy, after head and neck operation, esophagus cancer, postoperative esophagus cancer, after mediastinal radiation therapy, etc.) (2) Dysphagia caused by diseases in which progression is expected on a monthly basis such as neuromuscular disease and terminal stage of cancer (Allowance when progression in yearly unit is expected) (3) Acute onset Dysphagia (such as stroke) from acute to subacute (within 3 months after onset) (4) swallowing disorder expected to be relieved by medication treatment (autoimmune myositis etc, drug treatment ineffective cases are acceptable) (5) Drug-induced dysphagia (Those considered to require adjustment of medicines, allowance for invalid drug adjustment) (6) Respiratory dysfunction requiring oxygen administration (7) Severe heart failure (III or more in NYHA classification) (8) Active lower respiratory tract infection requiring antibiotic administration (9) Cases that the physician judged inappropriate
Target sample size	87

Research contact person
Name of lead principal investigator	Yukio Katori
Organization	Graduate School of Medicine, Tohoku University
Division name	Department of Otolaryngology, Head and Neck Surgery
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL	+81-22-717-7304
Email	yukio.katori.d1@tohoku.ac.jp

Public contact
Name of contact person	Kengo Kato
Organization	Graduate School of Medicine, Tohoku University
Division name	Department of Otolaryngology, Head and Neck Surgery
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL	+81-22-717-7304
Homepage URL
Email	engekato@gmail.com

Sponsor
Institute	Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Tohoku University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 10 Month 02 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 10 Month 02 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 10 Month 02 Day
Last modified on	2018 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039163