UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038945 |
|---|---|
| Receipt number | R000044403 |
| Scientific Title | Effect of high-flow nasal cannula oxygen therapy on exercise capacity in patients with Idiopathic Pulmonary Fibrosis |
| Date of disclosure of the study information | 2019/12/20 |
| Last modified on | 2020/12/22 19:23:22 |
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Basic information
Public title
Effect of high-flow nasal cannula oxygen therapy on exercise capacity in patients with Idiopathic Pulmonary Fibrosis
Acronym
Effect of high-flow nasal cannula oxygen therapy in patients with Idiopathic Pulmonary Fibrosis
Scientific Title
Effect of high-flow nasal cannula oxygen therapy on exercise capacity in patients with Idiopathic Pulmonary Fibrosis
Scientific Title:Acronym
Effect of high-flow nasal cannula oxygen therapy in patients with Idiopathic Pulmonary Fibrosis
Region
| Japan |
Condition
Condition
Idiopathic Pulmonary Fibrosis
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of high-flow nasal cannula oxygen therapy for exercise duration in patients with idiopathic pulmonary fibrosis who have exertion induced hypoxemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Endurance time of exercise
Key secondary outcomes
1. Dyspnea (modified Borg Scale)
2. Fatigue of lower limb (modified Borg Scale)
3. Desaturation (SpO2)
4. Heart rate
5. Blood pressure
6. Patient comfort to each device (Visual Analog Scale)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Arm A
A symptom-limited incremental exercise tests were carried out on cycle-ergometer with ambient air. Next time, patient performed constant-load symptom-limited exercise test in a random order arm A or arm B. A constant-load exercise test was performed at 80% of maximum workload achieved with the incremental test.
First time: constant-load exercise test with high-flow nasal cannula (60L/min, FiO2:0.5)
Second time: constant-load exercise test with venturi mask (FiO2:0.5).
Interventions/Control_2
Arm B
A symptom-limited incremental exercise tests were carried out on cycle-ergometer with ambient air. Next time, patient performed constant-load symptom-limited exercise test in a random order arm A or arm B. A constant-load exercise test was performed at 80% of maximum workload achieved with the incremental test.
First time: constant-load exercise test with venturi mask (FiO2:0.5)
Second time: constant-load exercise test with high-flow nasal cannula (60L/min, FiO2:0.5).
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient aged =<40 years at informed consent
2. Patient with idiopathic pulmonary fibrosis diagnosed according to the diagnostic criteria of INPULSIS trial and 2011 or 2018 ATS/ERS/JRS/ALAT guideline
3. Patients who have exercise induced oxygen desaturation (SpO2 <90%) during 6 minute walking test on ambient air
4. Patient with dyspnea on exercise (1 =< mMRC =< 3)
5. Stable patients without any infection nor acute exacerbation within 3 months
6. Patients who can see a doctor's visit to take outpatient rehabilitation program
7. Patients who can adequately answer the questionnaire about subjective symptom
8. Written informed consent is obtained
Key exclusion criteria
1. Patients with connective tissue disease, neuromuscular disease or orthopedic problem and other disease which may affect to exercise assessment and requires exercise limitation
2. Patients who have pulmonary hypertension, according to WHO guideline [I-II => NYHA and 25mmHg => mean pulmonary arterial pressure (40mmHg => TRPG)] and use a pulmonary vasodilator
3. Using an anti-arrhythmic drug
4. Using long-term oxygen therapy
5. Patients who cannot be evaluated by 6 minute walk test for any reason
6. Patients who are judged by the investigator as not adequate to participate in this study
7. History of malignant disease within 3 years
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Iwata |
Organization
Kobe City Medical Center General Hospital
Division name
Kobe City Medical Center General Hospital
Zip code
6500047
Address
2-1-1 Minatojima-minamimachi, Chuo-ward, Kobe-city, Hyogo
TEL
078-302-4321
iwaken@kcho.jp
Public contact
Name of contact person
| 1st name | Jumpei |
| Middle name | |
| Last name | Harada |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Rehabilitation
Zip code
6500047
Address
2-1-1 Minatojima-minamimachi, Chuo-ward, Kobe-city, Hyogo
TEL
078-302-4321
Homepage URL
jumpei_harada@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Department of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
No
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
Kobe City Medical Center General Hospital IRB
Address
2-1-1 Minatojima-minamimachi, Chuo-ward, Kobe-city, Hyogo
Tel
078-302-4321
rinken@kcho.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
| 2019 | Year | 12 | Month | 20 | 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
26
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
| 2019 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 12 | Month | 20 | Day |
Last modified on
| 2020 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044403
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| Registered date | File name |
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