UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037021
Receipt No. 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 2019/06/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email 18hm205e@shinshu-u.ac.jp

Sponsor
Institute Shinshu University, Graduate school of medicine science and technology
Institute
Department

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
Email 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 Open public recruiting
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
2019 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042176

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.