UMIN-CTR Clinical Trial

Basic information
Public title	Effects of comobidities on physical activity in COPD
Acronym	Co-mobidities and physical activity in COPD
Scientific Title	Effects of comobidities on physical activity in COPD
Scientific Title:Acronym	Co-mobidities and physical activity in COPD
Region	Japan

Condition
Condition	Chronic obstructive pulmonary disease (COPD)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate effects of co-mobidities on physical activity in COPD
Basic objectives2	Others
Basic objectives -Others	to explore risk factors
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Relation between comobidities and physical activity in stable COPD
Key secondary outcomes	Relation between lung function or exercise tolerance, and physical activity in stable COPD

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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	diagnosis of COPD
Key exclusion criteria	1) unable to respond questionnaire 2) unable to wear a 3-axis accelerometer 3) acute exacerbation within 2 month before enrollment 4) unable to walk
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Yoshida
Organization	National Hospital Organization Fukuoka Hospital
Division name	Division of Respiratory Medicine
Zip code	811-1394
Address	4-39-1 Yakatabaru, Minami-ku, Fukuoka 811-1394
TEL	092-565-5534
Email	yoshida.makoto.sv@mail.hosp.go.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Yoshida
Organization	National Hospital Organization Fukuoka Hospital
Division name	Division of Respiratory Medicine
Zip code	811-1394
Address	4-39-1 Yakatabaru, Minami-ku, Fukuoka 811-1394
TEL	092-565-5534
Homepage URL
Email	yoshida.makoto.sv@mail.hosp.go.jp

Sponsor
Institute	Department of pulmonary medicine, graduate school of medical & dental sciences, Kagoshima University
Institute
Department

Funding Source
Organization	The Ministry of Health Labour and Welfare, Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of pulmonary medicine, graduate school of medical & dental sciences, Kagoshima University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Hospital Organization Fukuoka Hospital
Address	4-39-1 Yakatabaru, Minami-ku, Fukuoka 811-1394
Tel	092-565-5534
Email	yoshida.makoto.sv@mail.hosp.go.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	国立病院機構福岡病院／National Hospital Organization Fukuoka Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 07 Day

Related information
URL releasing protocol	https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0270836
Publication of results	Published

Result
URL related to results and publications	https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0270836
Number of participants that the trial has enrolled	66
Results	Physical activity level was significantly correlated with step count, walking time, body mass index, lean body mass index, lung function, pulmonary artery pressure, depression, anxiety, and serum total cholesterol level. In a median regression model analysis, low lung function, low lean body mass index, depression, and low serum total cholesterol level were independently associated with decreased physical activity level.
Results date posted	2022 Year 08 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	COPD subjects who were stable over the previous 4 weeks were recruited.
Participant flow	We conducted a cross-sectional study with a series of tests assessing physical activity, lung function, and comorbidities.
Adverse events	None
Outcome measures	step count, walking time, body mass index, lean body mass index, lung function, pulmonary artery pressure, SDS, STAI, and serum total cholesterol level.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 06 Month 25 Day
Date of IRB	2014 Year 06 Month 23 Day
Anticipated trial start date	2014 Year 11 Month 05 Day
Last follow-up date	2016 Year 10 Month 31 Day
Date of closure to data entry	2022 Year 08 Month 01 Day
Date trial data considered complete	2022 Year 08 Month 01 Day
Date analysis concluded	2022 Year 08 Month 01 Day

Other
Other related information	Study design: cross-sectional study Subject recruitment: COPD outpatients regularly visiting National Hospital Organization Fukuoka Hosptal Recruiting period: from 01 NOV 2014 to 31 OCT 2016 Primary endpoint: effect of comorbidities on physical activity Secondary endpoint: effect of lung function, symptom, exacerbation history and respiratory failure on physical activity

Management information
Registered date	2016 Year 03 Month 05 Day
Last modified on	2022 Year 08 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024632