UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037021 |
|---|---|
| Receipt number | R000042176 |
| Scientific Title | Effects of respiratory rehabilitation on dynamic lung hyperinflation evaluated by hyperventilation in chronic obstructive pulmonary disease, an open label, randomized study |
| Date of disclosure of the study information | 2019/06/13 |
| Last modified on | 2022/04/19 09:18:26 |
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Basic information
Public title
Effects of respiratory rehabilitation on dynamic lung hyperinflation evaluated by hyperventilation in chronic obstructive pulmonary disease
Acronym
Effect of rehabilitation on dynamic lung hyperinflation by hyperventilation study
Scientific Title
Effects of respiratory rehabilitation on dynamic lung hyperinflation evaluated by hyperventilation in chronic obstructive pulmonary disease, an open label, randomized study
Scientific Title:Acronym
Effect of rehabilitation on dynamic lung hyperinflation by hyperventilation study
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is performed to elucidate the effects of respiratory rehabilitation for dynamic lung hyperinflation evaluated by hyperventilation in chronic obstructive pulmonary disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is defined as decrease in IC from rest by metronome-paced incremental hyperventilation (MPIH), which is an index of DLH.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Respiratory rehabilitation: The contents are shown below
1. 5 types of respiratory muscle stretch
Number of times:1 time or more / day
2. Inspiratory muscle training
Equipment used:POWER breathe PLUS
Number of times:30 times /2 sets / day and daily
3. aerobic exercise by walking (method of American Association of Cardiovascular Respiratory Rehabilitation)
Load:exercise load of up to 60% or more of the maximum exercise load (Work rate) obtained from the incremental load test, the subject is instructed to exercise 60% and exercise walking with reference to the Borg scale.
Number of times:20 minutes/day /3-5 times/week
Interventions/Control_2
Regular medication prescribed by a doctor
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
| 45 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
COPD patient group ( those who meet all the following criteria)
1. Patients diagnosed with COPD with 45 years of age or older (Global Initiative for Chronic Obstructive Lung Disease, 2019 report)
2. Patients who visited Shinshu University Hospital for the purpose of diagnosis and treatment of COPD
3. Patients who obtained informed consent for this study
4. Include asthma-COPD overlap syndrome
5. Patients who can go to the hospital once a month (every 4 weeks)
Key exclusion criteria
1. Patients who suffered from exacerbation or respiratory infection within 3 months from the time of obtaining consent
2. Patients who have difficulty in walking or filling in questionnaires due to the effects of motor function or cognitive function
3. Patients who have complications such as severe heart failure
4. Other patients who the research director judged inappropriate as a subject
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Kawachi |
Organization
Shinshu University
Division name
Graduate school of medicine science and technology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto sity, Nagano, Japan
TEL
0263372393
18hm205e@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Kawachi |
Organization
Shinshu University
Division name
Graduate school of medicine science and technology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto sity, Nagano, Japan
TEL
0263-37-2393
Homepage URL
18hm205e@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University, Graduate school of medicine science and technology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Medical Ethics Committee
Address
3-1-1, Asahi, Matsumoto sity, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.ac.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 | 06 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2024 | 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 | 06 | Month | 11 | Day |
Last modified on
| 2022 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042176
