UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048982 |
|---|---|
| Receipt number | R000055746 |
| Scientific Title | Characteristics of respiratory and cardiovascular responses during incremental load exercise tests for chronic respiratory disease |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2023/01/13 12:16:40 |
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Basic information
Public title
Characteristics of respiratory and cardiovascular responses during incremental load exercise tests for chronic respiratory disease
Acronym
Characteristics of respiratory and cardiovascular responses during incremental load exercise tests for chronic respiratory disease
Scientific Title
Characteristics of respiratory and cardiovascular responses during incremental load exercise tests for chronic respiratory disease
Scientific Title:Acronym
Characteristics of respiratory and cardiovascular responses during incremental load exercise tests for chronic respiratory disease
Region
| Japan |
Condition
Condition
Chronic respiratory disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness and specificity of CPET in patients with chronic respiratory disease.
Basic objectives2
Others
Basic objectives -Others
To clarify the usefulness and specificity of CPET in patients with chronic respiratory disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inspiratory duty cycle (Ti/Ttot)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
CRD patients visiting Jobu Hospital for Respiratory Diseases.
The patients going to hospital regularly.
The patients who agreed in written to join this clinical trial.
Key exclusion criteria
The patients with acute diseases, malignant diseases, bronchial asthma, agraphia or dementia.
Patients on oxygen therapy.
Absolute contraindication
-Acute myocardial infarction within 2 days
-Unstable angina that has not been stabilized by medical therapy
-Uncontrolled arrhythmia causing subjective symptoms or hemodynamic abnormalities
-Symptomatic severe aortic stenosis
-Uncontrolled symptomatic heart failure
-Acute pulmonary embolus or infarction
-Acute myocarditis or pericarditis
-Acute aortic dissection
-Uncontrolled mental disorder
Relative contraindications
-Stenosis of the left main coronary artery
-Moderate stenotic valvular disease
-Electrolyte abnormalities
-Severe hypertension
-Tachyarrhythmia or bradyarrhythmia
-Hypertrophic cardiomyopathy or other outflow tract stenosis
-Mental or physical impairment that precludes adequate exercise capacity
-Severe atrioventricular block
-Palpitations, shortness of breath, or chest pain before the examination
-Resting body temperature of 38.0 or higher
-Resting oxygen saturation less than 90%
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Uga |
Organization
Jobu hospital for respiratory diseases
Division name
Department of rehabilitation
Zip code
371-0048
Address
586-1, Taguchi, Maebashi, Gunma, JAPAN
TEL
027-232-5000
m11711024@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Uga |
Organization
Jobu hospital for respiratory diseases
Division name
Department of rehabilitation
Zip code
371-0048
Address
586-1, Taguchi, Maebashi, Gunma, JAPAN
TEL
027-232-5000
Homepage URL
m11711024@gunma-u.ac.jp
Sponsor or person
Institute
Jobu hospital for respiratory diseases
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Jobu hospital for respiratory diseases
Address
586-1, Taguchi, Maebashi, Gunma, JAPAN
Tel
027-232-5000
ichiyokai-jkn@mvd.biglobe.ne.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
JKNH202201
Org. issuing International ID_1
Institutional review board of Jobu hospital for respiratory diseases
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 | 09 | Month | 26 | 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
| 2022 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
case series study
Management information
Registered date
| 2022 | Year | 09 | Month | 21 | Day |
Last modified on
| 2023 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055746
| 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 |
