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
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
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
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
