UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048373 |
|---|---|
| Receipt number | R000055131 |
| Scientific Title | The characteristics of patients and breathing causing dynamic pulmonary hyperinflation, a factor in dyspnea in chronic obstructive pulmonary disease; a retrospective study. |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2022/07/14 11:44:48 |
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Basic information
Public title
The characteristics of patients and breathing causing dynamic pulmonary hyperinflation, a factor in dyspnea in chronic obstructive pulmonary disease; a retrospective study.
Acronym
The characteristics of patients and breathing causing dynamic pulmonary hyperinflation.
Scientific Title
The characteristics of patients and breathing causing dynamic pulmonary hyperinflation, a factor in dyspnea in chronic obstructive pulmonary disease; a retrospective study.
Scientific Title:Acronym
The characteristics of patients and breathing causing dynamic pulmonary hyperinflation.
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the characteristics of COPD patients causing dynamic lung hyperinflation in hyperventilation method.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to determine the threshold for dynamic lung hyperinflation limiting exercise in hyperventilation method.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The decrease of the inspiratory capacity after 20, 30, and 40 bpm of hyperventilations relative to the inspiratory capacity at rest, as a index of dynamic pulmonary hyperinflation.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
COPD patients
Patients aged 20 years or older diagnosed with chronic obstructive pulmonary disease (Guidelines for the Diagnosis and Treatment of COPD, 4th Edition, Japanese Respiratory Society)
Patients who visited Shinshu University Hospital for diagnosis and treatment of COPD.
Patients who have given written consent for participation and enrollment in clinical research.
Healthy volunteers
Healthy subjects over 18 years of age without respiratory disease or respiratory dysfunction.
Outpatients with diseases other than COPD, such as sleep apnea syndrome, who has normal respiratory function.
Persons who have given written consent for participation and enrollment in the clinical study.
Key exclusion criteria
Persons with heart failure.
Patients with exacerbations or respiratory infections within 3 months.
Patients with serious cardiac disease or arrhythmia.
Patients who have difficulty in walking due to motor or cognitive dysfunction.
Patients on long-term oxygen therapy.
Target sample size
174
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Kawachi |
Organization
Nagoya University
Division name
Department of Integrated Health Sciences Nagoya University Graduate School of Medicine
Zip code
461-0047
Address
1-1-20 Daiko-minami, Higashi-ku, Nagoya 461-8673, Japan
TEL
052-719-1365
kawachi@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Kawachi |
Organization
Nagoya University
Division name
Department of Integrated Health Sciences Nagoya University Graduate School of Medicine
Zip code
461-0047
Address
1-1-20 Daiko-minami, Higashi-ku, Nagoya 461-8673, Japan
TEL
052-719-1365
Homepage URL
kawachi@met.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2973
ethics@med.nagoya-u.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to determine the characteristics of COPD patients occuring dynamic lung hyperinflation and the threshold for dynamic lung hyperinflation that limits exercise in heperventilatiuon methods.
According to the classification of severity of airflow obstruction, COPD patients will be classified into 4 groups (mild, moderate, severe, and very severe airflow obstruction) based on the results of %FEV1, and the primary outcome will be compared between the 5 groups, including a healthy volunteer group. Furthermore, to characterize COPD patients who develop dynamic lung hyperinflation early in exercise, patients will be classified into three groups: one group that occur dynamic lung hyperinflation exceeding the clinically minimum important difference (MID) after 20 bpm of hyperventilation, one group that occur dynamic lung hyperinflation exceeding MID after 30 bpm pf hyperventilation, and one group that occur dynamic lung hyperinflation exceeding MID after 40 bpm pf hyperventilation. Secondary outcome will be comared between those three groups.
Management information
Registered date
| 2022 | Year | 07 | Month | 14 | Day |
Last modified on
| 2022 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055131
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