UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025459
Receipt number R000029290
Scientific Title Creation of the standard formula of physical activity in Japanese patients with COPD.
Date of disclosure of the study information 2017/01/10
Last modified on 2022/09/29 16:07:45

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Basic information

Public title

Creation of the standard formula of physical activity in Japanese patients with COPD.

Acronym

Standard formula of physical activity in COPD

Scientific Title

Creation of the standard formula of physical activity in Japanese patients with COPD.

Scientific Title:Acronym

Standard formula of physical activity in COPD

Region

Japan


Condition

Condition

COPD

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To create the standard formula of physical activity in Japanese patients with COPD

Basic objectives2

Others

Basic objectives -Others

exploration

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) the duration of physical activity at more than 3.0 METs

Key secondary outcomes

1) the duration of physical activity at more than 2.0 METs
2) average intensity of physical activity (METs・hr at more than 3.0 METs)
3) the total steps/day
4) the duration of physical activity at 1.0-1.5 METs


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

FEV1/FVC < 0.7

Key exclusion criteria

1) patients with bronchial asthma
2) patients received oxygen therapy
3) patients with history of lung resection
4) patients with history of COPD exacerbation among 3 months before entry
5) patients whose physical activities are extremely suppressed by diseases other than COPD

Target sample size

650


Research contact person

Name of lead principal investigator

1st name Yoshiaki
Middle name
Last name Minakata

Organization

National Hospital Organization Wakayama Hospital

Division name

Department of Respiratory Medicine

Zip code

644-0044

Address

1138 Wada Mihama-cho, Hidaka-gun, Wakayama, 644-0044, Japan

TEL

0738-22-3256

Email

minakata.yoshiaki.qy@mail.hosp.go.jp


Public contact

Name of contact person

1st name Yoshiaki
Middle name
Last name Minakata

Organization

National Hospital Organization Wakayama Hospital

Division name

Department of Respiratory Medicine

Zip code

644-0044

Address

1138 Wada Mihama-cho, Hidaka-gun, Wakayama, 644-0044, Japan

TEL

0738-22-3256

Homepage URL


Email

minakata.yoshiaki.qy@mail.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization Wakayama Hospital

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Central review board of National Hospital Organization

Address

2-5-21 Higashigaoka, Meguro-ku, Tokyo, 152-8621, Japan

Tel

03-5712-5075

Email

700-kenkyu@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



Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 10 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/34795478/

Publication of results

Partially published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/34795478/

Number of participants that the trial has enrolled

252

Results

Reference equations for the time of 1) the duration of physical activity at more than 3.0 METs, 2) those at more than 2.0 METs, 3) average intensity of physical activity, and 4) total steps/day could be created. However, the reference equation of 5) the duration of physical activity at 1.0-1.5 METs has not been completed.

Results date posted

2022 Year 09 Month 29 Day

Results Delayed


Results Delay Reason

A method to accurately extract the time of 1.0-1.5 METs from the measurement results has not been established, and is currently under consideration.

Date of the first journal publication of results

2021 Year 12 Month 09 Day

Baseline Characteristics

Analyzed number of patients (n=227)
Age 73.1+/-6.7 years
Gender[M/F] 213/14
FVC 3.28+/-0.78 L
FEV1 1.64+/-0.60 L
FEV1%pred 62.7+/-20.9 %
mMRC 1.2+/-0.9

Participant flow

No problem

Adverse events

None

Outcome measures

1) Reference equation for the duration of physical activity at more than 3.0 METs
2) Reference equation for the duration of physical activity at more than 2.0 METs
3) Reference equation for the average intensity of physical activity
4) Reference equation for the total steps/day
5) Reference equation for the duration of physical activity at 1.0-1.5 METs

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2016 Year 04 Month 11 Day

Date of IRB

2016 Year 11 Month 15 Day

Anticipated trial start date

2017 Year 01 Month 10 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 04 Month 06 Day

Date trial data considered complete

2020 Year 05 Month 29 Day

Date analysis concluded



Other

Other related information

We will compare the physical activity of Japanese patients with COPD evaluated by a triaxial accelerometer with the several factors including demographics, pulmonary function, exercise capacity, and indices of co-morbidity, and will extract the associated factors. Then we will create the formula of standard values of physical activity in COPD by using these factors.


Management information

Registered date

2016 Year 12 Month 28 Day

Last modified on

2022 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029290


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name