UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058841 |
|---|---|
| Receipt number | R000067281 |
| Scientific Title | Randomized controlled trial of multifactorial intervention for the prevention of lung function decline in elderly people at risk of chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2025/08/19 |
| Last modified on | 2025/08/19 16:48:05 |
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Basic information
Public title
Randomized controlled trial of multifactorial intervention for the prevention of lung function decline in elderly people at risk of chronic obstructive pulmonary disease
Acronym
Lung Advancement via Comprehensive Training, Integrated Nutrition, and Vitality Enhancement Taisho study
Scientific Title
Randomized controlled trial of multifactorial intervention for the prevention of lung function decline in elderly people at risk of chronic obstructive pulmonary disease
Scientific Title:Acronym
Lung Advancement via Comprehensive Training, Integrated Nutrition, and Vitality Enhancement Taisho study
Region
| Japan |
Condition
Condition
The risk of chronic obstructive pulmonary disease is higher for older people.
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effectiveness of a comprehensive program (exercise, lifestyle, nutrition) centered on exercise, including respiratory muscle training, for older people at risk of chronic obstructive pulmonary disease in a randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in lung function (forced expiratory volume in one second: FEV1) from the time of registration to 12 months after registration.
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
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 exercise classes covering 1) stretching, 2) strength training, 3) aerobic exercise, and 4) respiratory muscle training, held once a week for 90 minutes per session, totaling 52 sessions over one year (assuming 52 weeks).
Interventions/Control_2
Distribution of health education texts.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yutaro |
| Middle name | |
| Last name | Oki |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Public Health
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo 654-0142, JAPAN
TEL
078-796-4582
oki@carp.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yutaro |
| Middle name | |
| Last name | Oki |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Public Health
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo 654-0142, JAPAN
TEL
078-796-4582
Homepage URL
oki@carp.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Ethics Committee for Health Sciences
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo 654-0142, JAPAN
Tel
078-796-4502
syomu2@ams.kobe-u.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
大阪市大正区老人福祉センター
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 19 | 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
110
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067281
