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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028934
Receipt No. R000033098
Scientific Title Effects of the expiratory muscle strength training in dysphagia after pneumonia
Date of disclosure of the study information 2017/08/31
Last modified on 2018/09/01

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Basic information
Public title Effects of the expiratory muscle strength training in dysphagia after pneumonia
Acronym Expiratory muscle strength training in dysphagia after pneumonia
Scientific Title Effects of the expiratory muscle strength training in dysphagia after pneumonia
Scientific Title:Acronym Expiratory muscle strength training in dysphagia after pneumonia
Region
Japan

Condition
Condition swallowing disorders
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to assess the effect of the expiratory muscle strength training with four parameters including pharynx and larynx area movement, pulmonary function, respiratory muscle strength and cough peak flow in dysphagia patients after pneumonia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of a morphological characteristic of the pharynx and larynx area exercise after the 4-week expiratory muscule strength training.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 conventional treatment + expiratory muscle strength training (4 weeks, 5 days per week and 25 times per day, load is set at 75% of the participant's PEmax)
Interventions/Control_2 conventional treatment
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
18 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria A pneumonia inpatients who carry out swallowing rehabilitation.
Key exclusion criteria unstable hemodynamics
problem of the oral function
problem of the difficulty of understanding such as the cognitive impairment
neuromuscular disease
tracheotomy
bulbar palsy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Tawara
Organization Seirei Christopher University
Division name Department of Physical Therapy, School of Rehabilitation Sciences
Zip code
Address 3453 Mikatahara, Kita-ku, Hamamatsu, Shizuoka, Japan
TEL 053-439-1400
Email yuichi-t@seirei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Tawara
Organization Seirei Christopher University
Division name Department of Physical Therapy, School of Rehabilitation Sciences
Zip code
Address 3453 Mikatahara, Kita-ku, Hamamatsu, Shizuoka, Japan
TEL 053-439-1400
Homepage URL
Email yuichi-t@seirei.ac.jp

Sponsor
Institute Seirei Christopher University
Institute
Department

Funding Source
Organization Grant-in-Aid for scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

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 浜松市リハビリテーション病院

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 31 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 31 Day
Last modified on
2018 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033098

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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