UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042176