UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041250 |
|---|---|
| Receipt number | R000047101 |
| Scientific Title | Efficacy and applicability of expiratory pressure load training in patients with chronic obstructive pulmonary disease: a multicenter, randomized controlled trial |
| Date of disclosure of the study information | 2020/08/06 |
| Last modified on | 2023/08/01 15:14:42 |
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Basic information
Public title
Efficacy and applicability of expiratory pressure load training in patients with chronic obstructive pulmonary disease: a multicenter, randomized controlled trial
Acronym
EPT-study
Scientific Title
Efficacy and applicability of expiratory pressure load training in patients with chronic obstructive pulmonary disease: a multicenter, randomized controlled trial
Scientific Title:Acronym
EPT-study
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of expiratory pressure load training (EPT) for 12 weeks 1) in patients with severe and very severe chronic obstructive pulmonary disease (COPD) using confirmatory analyses; 2) in patients with mild to moderate COPD using searching analyses; and 3) to show how EPT confers these benefits, if any, a multicenter, randomized controlled trial was conducted.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endurance time, which will be evaluated by constant work rate exercise test during cardiopulmonary exercise testing (CPET) in patients with severe and very severe COPD.
Key secondary outcomes
1. Endurance time, which will be evaluated by constant work rate exercise test during CPET in patients with mild and moderate COPD.
2. In patients with severe and very severe COPD, or with mild and moderate COPD:
i) Symptom (SGRQ score: Total domain, Symptom, Activity, Impact)
ii) Respiratory function (RV, RV/TLC)
iii) During CPET, which will consist of incremental exercise test or constant work rate exercise test, the parameters: oxygen uptake (VO2), minute ventilation (VE), ventilatory equivalent, physiologic dead space/tidal volume ratio (VD/VT), expiratory tidal volume (VTex), mean expiratory flow (VTex/Te), inspiratory tidal volume (VTin), VTin-VTex, ratio of inspiratory time to total respiratory cycle time (Ti/Ttot) dyspnea (Borg scale), and collapse ratio of vocal cords using laryngeal scope, will be evaluated during exercise.
iv) Respiratory muscle pressure: maximum expiratory pressure (MEP)
v) 6-minute walk test: 6-minute walk distance
vi) Oxygen saturation of peripheral artery (SpO2) during the night
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Patients who meet the eligibility criteria will be enrolled and randomly assigned in a 1:1 ratio to be classified into the EPT group or the control group. In addition, patients in both groups will be classified to indicate the disease stage in equal populations. In the EPT group, the patients will receive EPT 30 times twice per day for 3 months. The load of EPT will be started at 20% of the maximum expiratory pressure obtained at baseline and can be increased once every 2 weeks to up to 50% of the maximum pressure.
Interventions/Control_2
The control group will not receive the intervention by EPT.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with COPD (FEV1/FVC < 70%, i.e., Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification airflow limitation severity, from I to IV)
2) Patients whose conditions are stable and who are able to tolerate cardiopulmonary exercise testing to ensure adequate evaluation
3) Patients who have signed the agreement for participation in this study
Key exclusion criteria
1) Patients with malignant tumors
2) Patients with active infection
3) Patients with severe heart disease
4) Patients with asthma
5) Patients whose drug regimen was changed during this study
6) Patients who are receiving pulmonary rehabilitation
7) Patients who receive oxygen therapy during exercise
8) Patients with a history of pneumothorax or who have a giant bulla with a high risk of developing pneumothorax
9) In addition to the above exclusion criteria, patients judged by their physician to be ineligible to participate in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Miki |
Organization
National Hospital Organization
Osaka Toneyama Medical Center
Division name
Department of Respiratory Medicine
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
TEL
0668532001
miki.keisuke.pu@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Miki |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Department of Respiratory Medicine
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
TEL
+81668532001
Homepage URL
miki.keisuke.pu@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Osaka Toneyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Clinical Research from National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Respiratory Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Osaka Toneyama Medical Center
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
Tel
0668532001
410-chiken@mail.hosp.go.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
| 2020 | Year | 08 | Month | 06 | 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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2020 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047101
