UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053767 |
|---|---|
| Receipt number | R000052008 |
| Scientific Title | Reliability and validity of cough peak flow measurement with myasthenia gravis |
| Date of disclosure of the study information | 2024/03/04 |
| Last modified on | 2024/09/08 10:05:01 |
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Basic information
Public title
Reliability and validity of cough peak flow measurement with myasthenia gravis
Acronym
Reliability and validity of cough peak flow measurement with myasthenia gravis
Scientific Title
Reliability and validity of cough peak flow measurement with myasthenia gravis
Scientific Title:Acronym
Reliability and validity of cough peak flow measurement with myasthenia gravis
Region
| Japan |
Condition
Condition
myasthenia gravis
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the association between the reliability of CPF measurement for MG patients and respiratory function and comprehensive assessment of MG. if the reliability and validity of CPF measurement for MG patients are clarified, MG symptoms related to respiratory function can be easily understood. If the reliability and validity of CPF measurement in MG patients can be clarified, it will provide a simple way to assess MG symptoms related to respiratory function. This study is clinically meaningful because it will provide a convenient evaluation index that can be performed by patients themselves at the bedside or at home, and it may enable appropriate treatment at the right time even if acute exacerbation of MG symptoms occurs.
Basic objectives2
Others
Basic objectives -Others
reliability and validity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cough peak flow measurement
Assessment at the time of admission and at the time of discharge
Key secondary outcomes
1) Pulmonary function tests (FVC, FVE1.0, IC, PEFR)
2) MG comprehensive assessment (QMG score, MG composite, MG ADL)
3) Whether or not self expectoration is possible (judged by the necessity of endotracheal suctioning)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In this study, patients who fulfill all of the following criteria will be included.
1) MG patients who were admitted to our hospital and underwent rehabilitation between January 2015 and December 2020
2) Patients who are 20 years old or older
3) Patients who have given consent for CPF measurement
Key exclusion criteria
(1) Patients who are unable to follow instructions due to impaired consciousness, dementia, or psychiatric symptoms
(2) Patients with poor control of subjective symptoms such as dyspnea and pain
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Yamanaka |
Organization
Chiba University Hospital
Division name
Urayasu Rehabilitation Education Center
Zip code
279-0023
Address
7-2-32 Takasu, Urayasu, Chiba
TEL
047-312-6765
y-yama@hospital.chiba-u.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Kuroiwa |
Organization
Chiba University Hospital
Division name
Division of rehabilitation medicine
Zip code
260-8677
Address
1-8-1 Inohana Chuo-ku, Chiba city
TEL
043-222-7171
Homepage URL
pseudoarthrosis7@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding source
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
Independent Ethics Committee of Graduate School of Medicine and School of Medicine, Chiba University
Address
1-8-1 Inohana Chuo-ku, Chiba city
Tel
043-226-2501
igaku-kouhou@chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000052008
Publication of results
Unpublished
Result
URL related to results and publications
no yet
Number of participants that the trial has enrolled
26
Results
The intraclass correlation coefficient was more than 0.95 for pre-and post-treatment. Positive correlations were found between CPF and almost all spirometric values as well as between the differences of pre-and post-treatment in CPF and quantitative myasthenia gravis.
Results date posted
| 2024 | Year | 03 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
MG patients (n = 26)
Age (years) 55.1 (19.5)
Gender (male/female) 7/19
Height (cm) 158.3 (7.8)
Weight (kg) 57.4 (10.2)
Participant flow
Information was collected from medical record entries for a retrospective observational study.
Adverse events
No adverse events
Outcome measures
CPF, respiratory function tests, MG comprehensive evaluation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 10 | Month | 07 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 04 | Day |
Other
Other related information
Decreased cough strength in MG leads to aspiration and increases the risk of MG crisis. In our study, we clarified the reliability and validity of cough peak flow (CPF) measurements in MG. For 26 patients with MG who underwent CPF measurements using the peak flow meter by themselves, MG symptoms were evaluated by pulmonary function tests and clinical MG assessment scales pre- and post- immune treatments. The relationship between CPF and pulmonary function tests and MG comprehensive were assessed. There are 4 main findings. (i) The intraclass correlation coefficient was more than 0.95 for pre-and post-treatment, indicating reliability of CPF. (ii) Positive correlations were found between CPF and almost all spirometric values as well as between the differences between pre-and post-treatment in CPF and Quantitative myasthenia gravis score. (iii) The CPF for identifying the aspiration risk was used to calculate the CPF cut-off value of 205 L/min with a sensitivity of 0.77, specificity of 0.9, and area under the curve of 0.85. (iv) Measurement of CPF in MG patients is a highly reliable method that can be measured by the patients themselves.
Management information
Registered date
| 2024 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052008
