UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047834
Receipt number R000054533
Scientific Title The single-institutional prospective observational study to evaluate the severity of the pulmonary disease using the data of the physical activity.
Date of disclosure of the study information 2022/05/23
Last modified on 2022/05/23 15:01:52

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Basic information

Public title

The single-institutional prospective observational study to evaluate the severity of the pulmonary disease using the data of the physical activity.

Acronym

Prospective observational study of physical activity in patients with pulmonary disease

Scientific Title

The single-institutional prospective observational study to evaluate the severity of the pulmonary disease using the data of the physical activity.

Scientific Title:Acronym

Prospective observational study of physical activity in patients with pulmonary disease

Region

Japan


Condition

Condition

COPD, Interstitial pneumonia, lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate physical activity by ePRO in patients with pulmonary disease.
Physical activity will be collected for 2 weeks to investigate the association with mMRC in interstitial pneumonia, GOLD classification in COPD, and ECOG PS in lung cancer at the time of study.

Basic objectives2

Others

Basic objectives -Others

To evaluate the availability of ePRO as a method for measuring physical activity.
6/12/18 months will be observed for chest disease events and death events.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

AUC by ROC analysis for severity based on the pulmonary disease.

Key secondary outcomes

Sensitivity, Specificity, Accuracy rate for each ROC analysis


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

Inclusion criteria
1. Diagnosed with pulmonary disease as below: COPD, interstitial pneumonia, lung cancer.
2. Pulmonary function test, Chest CT is planned.
3. Can use the ePRO device for measuring physical activity.
4. Written informed consent

Key exclusion criteria

None

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Kentaro
Middle name
Last name Ito

Organization

Matsusaka Municipal Hospital

Division name

Respiratory Center

Zip code

5150073

Address

1550, Tonomachi, Matsusaka City, Mie, Japan

TEL

0598231515

Email

kentarou_i_0214@yahoo.co.jp


Public contact

Name of contact person

1st name Kentaro
Middle name
Last name Ito

Organization

Matsusaka Municipal Hospital

Division name

Respiratory Center

Zip code

5150073

Address

1550, Tonomachi, Matsusaka City, Mie, Japan

TEL

0598231515

Homepage URL


Email

kentarou_i_0214@yahoo.co.jp


Sponsor or person

Institute

Matsusaka Municipal Hospital

Institute

Department

Personal name



Funding Source

Organization

Matsusaka Municipal Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Matsusaka Municipal Hospital

Address

1550, Tonomachi, Matsusaka City, Mie, Japan

Tel

0598231515

Email

kentarou_i_0214@yahoo.co.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

2022 Year 05 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


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

Enrolling by invitation

Date of protocol fixation

2021 Year 05 Month 02 Day

Date of IRB

2021 Year 06 Month 04 Day

Anticipated trial start date

2021 Year 07 Month 01 Day

Last follow-up date

2023 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Physical activity will be collected for 2 weeks to investigate the association with mMRC in interstitial pneumonia, GOLD classification in COPD, and ECOG PS in lung cancer at the time of study. 6/12/18 months will be observed for chest disease events and death events.


Management information

Registered date

2022 Year 05 Month 23 Day

Last modified on

2022 Year 05 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054533


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name