UMIN-CTR Clinical Trial

Basic information
Public title	Long-term effects of pulmonary rehabilitation for chronic obstructive pulmonary disease
Acronym	Long-term effects of pulmonary rehabilitation for chronic obstructive pulmonary disease
Scientific Title	Long-term effects of pulmonary rehabilitation for chronic obstructive pulmonary disease
Scientific Title:Acronym	Long-term effects of pulmonary rehabilitation for chronic obstructive pulmonary disease
Region	Japan

Condition
Condition	Chronic Obstructive Pulmonary Disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effect of prevention of Chronic Obstructive Pulmonary Disease exacerbations with and without outpatient pulmonary rehabilitation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of exacerbations of chronic obstructive pulmonary disease
Key secondary outcomes	Pulmonary function Resting oxygen flow rate Number of visits to the hospital Body Mass Index Co-morbidities

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Chronic Obstructive Pulmonary Disease patients who have been on continuous outpatient respiratory rehabilitation for at least 12 months between January 1, 2013 and December 31, 2019. 2. Chronic Obstructive Pulmonary Disease patients who had 12 or more regular visits between January 1, 2019 and December 31, 2019, regardless of when the outpatient visit began.
Key exclusion criteria	Patients in need of support or care
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shota Middle name Last name Suzuki
Organization	Jobu Hospital for Respiratory Diseases
Division name	Department of Rehabilitation
Zip code	371-0048
Address	586-1,Taguchi,Maebashi,Gunma,JAPAN
TEL	027-232-5000
Email	m13204010@gunma-u.ac.jp

Public contact
Name of contact person	1st name Shota Middle name Last name Suzuki
Organization	Jobu Hospital for Respiratory Diseases
Division name	Department of Rehabilitation
Zip code	371-0048
Address	586-1,Taguchi,Maebashi,Gunma,JAPAN
TEL	027-232-5000
Homepage URL
Email	m13204010@gunma-u.ac.jp

Sponsor
Institute	Jobu Hospital for Respiratory Diseases
Institute
Department

Funding Source
Organization	Jobu Hospital for Respiratory Diseases
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Jobu Hospital for Respiratory Diseases
Address	586-1,Taguchi,Maebashi,Gunma,JAPAN
Tel	027-232-5000
Email	Ichiyokai-jkn@mvd.biglobe.ne.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	医療法人一羊会　上武呼吸器科内科病院（群馬県）

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 23 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	93
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 10 Month 23 Day
Date of IRB	2020 Year 10 Month 24 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 10 Month 19 Day
Last modified on	2022 Year 04 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048061