UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058488 |
|---|---|
| Receipt number | R000066855 |
| Scientific Title | Portable Cardiopulmonary Assessment in ILD: Prospective Interventional Study Comparing Three Exercise Testing Modalities |
| Date of disclosure of the study information | 2025/07/16 |
| Last modified on | 2025/07/16 11:42:55 |
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Basic information
Public title
Portable Cardiopulmonary Assessment in ILD: Prospective Interventional Study Comparing Three Exercise Testing Modalities
Acronym
Portable Cardiopulmonary Assessment in ILD: Prospective Interventional Study Comparing Three Exercise Testing Modalities
Scientific Title
Portable Cardiopulmonary Assessment in ILD: Prospective Interventional Study Comparing Three Exercise Testing Modalities
Scientific Title:Acronym
Portable Cardiopulmonary Assessment in ILD: Prospective Interventional Study Comparing Three Exercise Testing Modalities
Region
| Japan |
Condition
Condition
Interstitial Lung Disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Three types of exercise tests will be performed and evaluated with a portable respiratory gas exchange analyzer for comparison. Exercise tolerance and cardiopulmonary responses will be evaluated and their relationship to severity will be investigated.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
peak oxygen uptake, anaerobic metabolic threshold, peak work rate, VE/VCO2 for each exercise test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants will wear a portable respiratory gas exchange analyzer and perform three types of exercise tests.
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
Patients will be deemed eligible for the study if they are diagnosed with interstitial lung disease, clinically stable, and have no pulmonary rehabilitation session for the passed 6 months.
Key exclusion criteria
People with CRD will be excluded if they (i) have the potential to cause significant hypoxemia with exercise; (ii) require nasal cannula oxygenation (including home oxygen therapy) ; (iii) have complications or disabilities that make exercise difficult; (iv) have cardiac disease that puts participants at risk for exercise; (v) forbidden by their doctors to exercise; (vi) have inadequate understanding of exercise stress testing; (vii) are diagnosed with dementia; (viii) have visual or hearing problems in performing exercise training
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Atsuhito |
| Middle name | |
| Last name | Nakazawa |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine
Zip code
236-0051
Address
6-16-1, Tomioka-higashi, Kanazawa-ku Yokohama
TEL
045-701-9581
gda_kawasaki@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Atsuhito |
| Middle name | |
| Last name | Nakazawa |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine
Zip code
236-0051
Address
6-16-1, Tomioka-higashi, Kanazawa-ku Yokohama
TEL
045-701-9581
Homepage URL
gda_kawasaki@yahoo.co.jp
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cardiovascular and Respiratory Center
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
Kanagawa Cardiovascular and Respiratory Center
Address
6-16-1, Tomioka-higashi, Kanazawa-ku Yokohama
Tel
0457019581
gda_kawasaki@yahoo.co.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
| 2025 | Year | 07 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 07 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066855
