UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050746 |
|---|---|
| Receipt number | R000057801 |
| Scientific Title | Efficacy and safety of high-intensity, low-frequency expiratory pressure load training in patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2023/04/03 |
| Last modified on | 2023/04/01 18:17:21 |
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Basic information
Public title
Efficacy and safety of high-intensity, low-frequency expiratory pressure load training in patients with chronic obstructive pulmonary disease
Acronym
HILF-EPT study
Scientific Title
Efficacy and safety of high-intensity, low-frequency expiratory pressure load training in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym
HILF-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 efficacy and safety of high-intensity, low-frequency expiratory pressure load training (EPT) for 12 weeks in patients with chronic obstructive pulmonary disease (COPD) suffering from progressive external dyspnea.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the 6-min walk distance and the increase in the modified Borg scale at 12 weeks.
Key secondary outcomes
Respiratory muscle pressure, CAT, NRADL, body composition, handgrip strength, five times sit-to-stand test.
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The patients will receive standard pulmonary rehabilitation in addition to EPT 30 times (5 times x 6 sets) per day, 3 days a week for 12 weeks. There is a 1 minute interval between each set, and the patients have at least one rest day after training day. The load of EPT will be increased to 60-80% of the maximum expiratory pressure, which will be adjusted at 6 week.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
2) Patients underwent pulmonary rehabilitation, but complaining of progressive external dyspnea.
3) Patients whose conditions are stable and who are able to tolerate the 6-min walk test to ensure adequate evaluation.
4) Patients provided written informed consent to participate in this study.
Key exclusion criteria
1) Patients with active infection.
2) Patients with severe heart disease.
3) Patients whose drug regimen was changed during this study.
4) Patients with a high risk of developing pneumothorax.
5) In addition to the above exclusion criteria, patients judged by their physician to be ineligible to participate in this study.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Yanai |
Organization
Japanese Red Cross Ishinomaki Hospital
Division name
Department of Respiratory Medicine
Zip code
986-8522
Address
71 Nishimichishita, Hebita, Ishinomaki, Miyagi, Japan
TEL
0225-21-7220
myan_2@hotmail.com
Public contact
Name of contact person
| 1st name | Seiichi |
| Middle name | |
| Last name | Kobayashi |
Organization
Japanese Red Cross Ishinomaki Hospital
Division name
Department of Respiratory Medicine
Zip code
986-8522
Address
71 Nishimichishita, Hebita, Ishinomaki, Miyagi, Japan
TEL
0225-21-7220
Homepage URL
skoba-thk@umin.ac.jp
Sponsor or person
Institute
Japanese Red Cross Ishinomaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Ishinomaki Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ishinomaki COPD Network(ICON)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Japanese Red Cross Ishinomaki Hospital
Address
71 Nishimichishita, Hebita, Ishinomaki, Miyagi, Japan
Tel
0225-21-7220
i-hosp@ishinomaki.jrc.or.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
石巻赤十字病院（宮城県）、斎藤病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 03 | 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
| 2023 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 01 | Day |
Last modified on
| 2023 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057801
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
