UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028934 |
|---|---|
| Receipt number | 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 | 2023/09/19 10:59:52 |
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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 | Yuichi |
| Middle name | |
| Last name | Tawara |
Organization
Seirei Christopher University
Division name
Department of Physical Therapy, School of Rehabilitation Sciences
Zip code
4338558
Address
3453 Mikatahara, Kita-ku, Hamamatsu, Shizuoka, Japan
TEL
053-439-1400
yuichi-t@seirei.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Tawara |
Organization
Seirei Christopher University
Division name
Department of Physical Therapy, School of Rehabilitation Sciences
Zip code
4338558
Address
3453 Mikatahara, Kita-ku, Hamamatsu, Shizuoka, Japan
TEL
053-439-1400
Homepage URL
yuichi-t@seirei.ac.jp
Sponsor or person
Institute
Seirei Christopher University
Institute
Department
Personal name
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
Seirei Christopher University
Address
3453 Mikatahara, Kita-ku, Hamamatsu, Shizuoka, Japan
Tel
0534391400
yuichi-t@seirei.ac.jp
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
| 2017 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033098
| 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 |
