Randomized controlled trial of multifactorial intervention for the prevention of lung function decline in elderly people at risk of chronic obstructive pulmonary disease

Randomized controlled trial of multifactorial intervention for the prevention of lung function decline in elderly people at risk of chronic obstructive pulmonary disease - J-BREATH Taisho study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058841

Enrollment

100

Registered

2025-08-19

Start date

2025-04-07

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The risk of chronic obstructive pulmonary disease is higher for older people.

Interventions

Implement a multifactorial intervention program consisting of an exercise program and a group work program focused on lifestyle habits and nutrition. The exercise program will consist of group exerci

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) At the time of registration, you must be a resident of Taisho Ward, Osaka City, and 60 years of age or older. 2) Smoking history (including passive smoking). Passive smoking refers to daily or occasional exposure to smoke from other smokers in the home or workplace. 3) No diagnosis of COPD. 4) Dementia assessment (DASC-21) score of less than 31 points.

Exclusion criteria

Exclusion criteria: 1) No history of smoking, including passive smoking. 2) Severe functional impairment requiring prohibition or restriction of movement, eating, or drinking (including bone and joint diseases, renal failure, ischemic heart disease, or cardiopulmonary dysfunction). 3) Diagnosed with dementia. 4) Even if not meeting exclusion criterion 2), if the attending physician or primary care physician determines that the subject is unsuitable for the study while undergoing outpatient treatment.

Design outcomes

Primary

Measure	Time frame
Change in lung function (forced expiratory volume in one second: FEV1) from the time of registration to 12 months after registration.	—

Secondary

Measure	Time frame
1) Changes in respiratory muscle strength (inspiration and expiration) from the initial assessment to the 6-, 12-, and 18-month follow-up assessments 2) Changes in subjective fatigue levels from the initial assessment to the 6-, 12-, and 18-month follow-up assessments 3) Changes in the COPD Assessment Test scores from the initial assessment to the 6-, 12-, and 18-month follow-up assessments 4) Changes in frailty from the initial assessment to the 6-, 12-, and 18-month follow-up assessments	—

Measure

Time frame

1) Changes in respiratory muscle strength (inspiration and expiration) from the initial assessment to the 6-, 12-, and 18-month follow-up assessments 2) Changes in subjective fatigue levels from the initial assessment to the 6-, 12-, and 18-month follow-up assessments 3) Changes in the COPD Assessment Test scores from the initial assessment to the 6-, 12-, and 18-month follow-up assessments 4) Changes in frailty from the initial assessment to the 6-, 12-, and 18-month follow-up assessments

—

Countries

Japan

Contacts

Public ContactYutaro Oki

Kobe University Graduate School of Health Sciences Department of Public Health

oki@carp.kobe-u.ac.jp078-796-4582

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026