UMIN-CTR Clinical Trial

Public title

Clinical Applications of CT-Based Lung Volume Assessment in Patients with Interstitial Lung Disease

Acronym

Clinical Applications of Lung Volume Assessment in Interstitial Lung Disease

Scientific Title

Relationship Between Lung Volume and Endurance and Quality of Life in Patients with Interstitial Lung Disease

Scientific Title:Acronym

Relationship Between Lung Volume and Endurance and QOL in Interstitial Lung Disease

Region

Japan

Condition

Interstitial Lung Disease

Classification by specialty

Pneumology

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aimed to investigate the association between CT-based lung volumes and clinical symptoms (e.g., endurance and QOL) in patients with ILD.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Lung volume were evaluated at diagnosis and at 1 and 2 years of follow-up.

Key secondary outcomes

6-minute walk distance and the COPD Assessment Test were evaluated at diagnosis and at 1 and 2 years of follow-up.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

40

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients with interstitial lung disease who visited the Department of Respiratory Medicine at our hospital between 2017 and 2022

Key exclusion criteria

The exclusion criteria included patients who were unable to undergo CT imaging, those unable to perform 6MWT, those who had difficulty understanding instructions, patients receiving mechanical ventilation, and those with heart disease or cerebrovascular disease requiring treatment.

Target sample size

60

Name of lead principal investigator

1st name	Masashi
Middle name
Last name	Zenta

Organization

International University of Health and Welfare, Ichikawa Hospital

Division name

Division of Rehabilitation

Zip code

272-0827

Address

6-1-14 Ichikawa, Kounodai, Chiba, Japan

TEL

047-375-1111

Email

m-zenta@ihwg.jp

Name of contact person

1st name	Masashi
Middle name
Last name	Zenta

Organization

International University of Health and Welfare, Ichikawa Hospital

Division name

Division of Rehabilitation

Zip code

272-0827

Address

6-1-14 Ichikawa, Kounodai, Chiba, Japan

TEL

047-375-1111

Homepage URL

Email

m-zenta@ihwg.jp

Institute

Division of Rehabilitation, International University of Health and Welfare, Ichikawa Hospital

Institute

Department

Personal name

Organization

Grant-in-Aid for Scientific Research (Grant Number JP23K16580) from the Japan Society for the Promotion of Science (JSPS)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

The Ethics Review Committee of Chiba District

Address

6-1-14 Ichikawa, Kounodai, Chiba, Japan

Tel

047-375-1111

Email

rinri_md@ihwg.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

03

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2026

Year

01

Month

27

Day

Date of IRB

2026

Year

01

Month

30

Day

Anticipated trial start date

2026

Year

02

Month

09

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(1) Pharmaceuticals, Medical Devices, and Measurement Methods Used in This Study

Aquilion PRIME (Canon Medical Systems Corporation, Tochigi, Japan): Used for chest computed tomography (CT) imaging.
Ziostation2 (Ziosoft Inc., Tokyo, Japan): Used for the calculation of thoracoabdominal skeletal muscle area at the T12 level (SMA-T12) and lung volume.

(2) Evaluation Items and Methods
1) Primary Outcomes

Thoracoabdominal skeletal muscle area at the T12 level (SMA-T12) calculated from chest CT images, activities of daily living (ADL) assessed using the Nagasaki University Respiratory ADL questionnaire (NRADL), and quality of life (QOL) assessed using the COPD Assessment Test (CAT) will be evaluated.

2) Secondary Outcomes

The following variables will be collected and analyzed as potential related factors: age, sex, height, weight, lung volume, vital capacity (VC), forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLco), forced expiratory volume in one second (FEV1), arterial oxygen partial pressure (PaO2), arterial carbon dioxide partial pressure (PaCO2), Krebs von den Lungen-6 (KL-6), C-reactive protein (CRP), and serum albumin (ALB), 6-minute walk distance(6MWD).

Registered date

2026

Year

03

Month

13

Day

Last modified on

2026

Year

03

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068775