UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021358
Receipt number R000024632
Scientific Title Effects of comobidities on physical activity in COPD
Date of disclosure of the study information 2016/03/07
Last modified on 2022/08/01 10:36:32

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024632


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name