UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053534 |
|---|---|
| Receipt number | R000057553 |
| Scientific Title | Effectiveness of cough training using a peak flow meter in patients with Parkinson's disease |
| Date of disclosure of the study information | 2024/02/18 |
| Last modified on | 2024/02/04 12:00:22 |
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Basic information
Public title
Effectiveness of cough training using a peak flow meter in patients with Parkinson's disease
Acronym
cough training
Scientific Title
Effectiveness of cough training using a peak flow meter in patients with Parkinson's disease
Scientific Title:Acronym
effectiveness of cough training
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
According to the Ministry of Health, Labour and Welfare (MHLW), malignant neoplasms were the leading cause of death in Japan in 2021, but aspiration pneumonia was the sixth leading cause, with 49,489 deaths per year. Aspiration pneumonia is a form of pneumonia associated with dysphagia, and is caused by stroke, which accounts for about six per cent of deaths, followed by Parkinson's disease (PD) and spinocerebellar degeneration, which are the most common neurological disorders in people suffering from aspiration pneumonia. As a cause and mechanism of aspiration pneumonia, it is caused by an increase in bacteria in the oral cavity, a decline in immunity due to ageing, and a decline in swallowing function combined with a decline in coughing function. Aspiration pneumonia is basically treated with antimicrobial drugs. As a training method to prevent aspiration pneumonia in PD patients, expiratory muscle training has been shown to improve expiratory muscle strength and coughing power (hereafter CPF), and to have an effect on swallowing function (Yanagisawa et al., 2012). In particular, it has been shown to be more effective than expiratory muscle training. (Reyes et al., 2018). On the other hand, there is a report (Kaneko et al.,2022) that cough training using a peak flow meter for elderly patients was effective in improving cough force, but the effect on PD patients has not been verified. training to improve CPF in PD patients would provide a new way to reduce the risk of aspiration pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
CPF (cough peak flow): measured in a sitting position using a spirometer and face mask.
Key secondary outcomes
Basic information.
Gender, age, height, weight, BMI
Medical information
Diagnosis, co-morbidities, medication status
Grip strength
Average of maximum left and right hand values. The subject is measured in a sitting position with the upper limbs lowered vertically from the floor.
Respiratory muscle strength
Maximum inspiratory pressure, maximum expiratory pressure, exertional lung capacity, one-second rate. Measured using an intraoral manometer with the subject in a sitting position with the mouthpiece applied with the mouth.
Thoracic mobility.
Scale values for the upper thorax, lower thorax and abdomen. The subject measures scale values in the upper thorax, lower thorax and abdomen using a respiratory kinematometer in the back lying position.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Subjects were randomly divided into two groups, intervention and control, for a fixed period of time (washout) and the conditions were switched.
Interventions/Control_2
same
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
Patients for whom sitting is possible with monitoring and does not pose a measurement risk.
Patients with PD
Key exclusion criteria
Patients with chronic obstructive disease.
Patients with cerebrovascular disease.
Patients with other progressive neurological disorders.
Patients who are unable to sit up.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | kaneko |
| Middle name | |
| Last name | hideo |
Organization
International University of Health and Welfare Graduate School
Division name
Rehabilitation
Zip code
814-0001
Address
2-4-16, Momochihama, Sagara-ku, Fukuoka City, Fukuoka Prefecture, Japan
TEL
0928321200
hkaneko@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Urushidani |
| Middle name | |
| Last name | Kouichi |
Organization
TokushukaiHospital,Futsukaichi
Division name
Rehabilitation room
Zip code
818-0072
Address
4-8-25,FutsukaichiChuo, Chikushino, Fukuoka, Japan
TEL
0929222531
Homepage URL
22s1024@g.iuhw.ac.jp
Sponsor or person
Institute
TokushukaiHospital,Futsukaichi
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare Graduate School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Tokushukai Hospital Ethics Committee
Address
4-5 Sukukita, Kasuga, Fukuoka, Japan
Tel
0925736622
mizota@csf.ne.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
二日市徳洲会病院/TokushukaiHospital,Futsukaichi
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 18 | 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
4
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
| 2022 | Year | 12 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057553
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| Registered date | File name |
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