UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039439
Receipt number R000044963
Scientific Title Effects of chronic pulmonary diseases on instrumental activities of daily living and related factors.
Date of disclosure of the study information 2020/02/08
Last modified on 2023/05/21 13:34:02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effects of chronic pulmonary diseases on instrumental activities of daily living and related factors.

Acronym

Effects of chronic pulmonary diseases on instrumental activities of daily living and related factors.

Scientific Title

Effects of chronic pulmonary diseases on instrumental activities of daily living and related factors.

Scientific Title:Acronym

Effects of chronic pulmonary diseases on instrumental activities of daily living and related factors.

Region

Japan


Condition

Condition

chronic obstructive pulmonary disease
interstitial pneumonias

Classification by specialty

Pneumology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effects of chronic pulmonary diseases on instrumental activities of daily living and related factors.

Basic objectives2

Others

Basic objectives -Others

To clarify the status of instrumental activities of daily living in patients with chronic pulmonary disease.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. instrumental activities of daily living

Key secondary outcomes

1. patient characteristics
2. pulmonary function
3. physical activity
4. physical function
5. quality of life
6. activities of daily living
7. body composition


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

Patients aged 40 years or older with routine follow-up at the research hospital due to chronic obstructive pulmonary disease or interstitial pneumonia, regardless of severity.

Key exclusion criteria

1. Patients with acute exacerbation at regular evaluation (within the past month) .
2. Patients who have difficulty communicating at the interview and cannot fill out the questionnaire.
3. Patients who are taking psychiatric outpatients for mental illness.
4. Patients without informed consent.

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Hajime
Middle name
Last name Kurosawa

Organization

Tohoku University

Division name

Department of Occupational Health, Tohoku University Graduate School of Medicine

Zip code

980-8575

Address

2-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7874

Email

kurosawa-thk@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Tomoyuki
Middle name
Last name Murakami

Organization

Tohoku University

Division name

Department of Occupational Health, Tohoku University Graduate School of Medicine

Zip code

980-8575

Address

2-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7874

Homepage URL


Email

tmurakami@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tohoku Medical and Pharmaceutical University Wakabayashi Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohoku University

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

Tel

022-717-8006

Email

med-kenkyo@grp.tohoku.ac.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

2020 Year 02 Month 08 Day


Related information

URL releasing protocol

https://doi.org/10.15032/jsrcr.21-03

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.15032/jsrcr.21-03

Number of participants that the trial has enrolled

74

Results

The mean FAI score was 20.2 points, and the FAI was significantly correlated with each index of clinical severity, respiratory function, ADL, physical activity, and exercise tolerance. In particular, physical activity was strongly related to the duration of high-intensity light physical activity (2.0-2.9METs) and was a contributing factor in multiple regression analysis. Four factors extracted by factor analysis were also correlated with factors related to physical activity.

Results date posted

2023 Year 05 Month 21 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The results of the 74 patients with stable COPD included in this study were as follows. The mean FAI was 20.2 points, mean age 74.9 years, %FEV1 57.8%, BMI 22.5 kg/m2, 89% male, and 20% use of home oxygen therapy use. Most of the patients were independent in basic ADL with a median BI of 100.

Participant flow

Patients with stable COPD aged 40 years or older were followed up regularly at the outpatient department of respiratory medicine, Tohoku Medical and Pharmaceutical University Wakabayashi Hospital from December 2019 to March 2021. The study subjects gave verbal consent in writing at the time of evaluation. Exclusion criteria were as follows: (1) patients with exacerbations (within the past month) at the time of periodic evaluation, (2) patients who had communication difficulties and were unable to complete the questionnaire, (3) patients with psychiatric disorders who were taking psychiatric medication, and (4) patients who could not give informed consent.

Adverse events

Nothing.

Outcome measures

Main outcome: FAI
Secondary outcome: patient background, respiratory function, ADL, QOL, physical activity, exercise tolerance, body composition

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 11 Month 10 Day

Date of IRB

2019 Year 11 Month 28 Day

Anticipated trial start date

2019 Year 12 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is observational prospective study.
We will investigate instrumental activities of daily living, patient characteristics, physical activity, physical function, pulmonary function, activities of daily living, quality of life, and body composition.


Management information

Registered date

2020 Year 02 Month 08 Day

Last modified on

2023 Year 05 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044963


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name