UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056694 |
|---|---|
| Receipt number | R000064801 |
| Scientific Title | Examination of the factors related to long-term physical activity maintenance in patients with COPD |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2026/02/13 15:17:35 |
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Basic information
Public title
Examination of the factors related to long-term physical activity maintenance in patients with COPD
Acronym
LOPAM study
Scientific Title
Examination of the factors related to long-term physical activity maintenance in patients with COPD
Scientific Title:Acronym
LOPAM study
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the impact of providing step goals for six months on step count three years later.
Basic objectives2
Others
Basic objectives -Others
We will investigate the impact of providing step goals for six months on physical activity three years later, the impact of maintaining physical activity at six months on physical activity three years later, and the characteristics of patients who were able to maintain physical activity over three years.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in change in step counts after 3 years between the group that received step count goals for 6 months and the control group
Key secondary outcomes
Between-group differences in changes in physical activity parameters other than step counts (duration at 3.0 METs or more, duration at 2.0 METs or more, duration at 1.0-1.5 METs, total activity at 3.0 METs or more) after 3 years
Correlation between change in step count from baseline after 6 months and 3 years
Correlation between changes in physical activity parameters other than number of steps from baseline after 6 months and 3 years
Correlation between change in step count over 3 years and baseline patient characteristics
Correlation between change in number of steps and change in patient characteristics after 3 years
Correlation between changes in physical activity parameters other than step count over 3 years and baseline patient characteristics
Correlation between changes in physical activity parameters other than step counts and changes in patient characteristics after 3 years
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 are eligible for enrollment if they have been enrolled in a previous study, "Effects of providing individual target step count for 6 months on the number of steps in patients with COPD (UMIN000046390)" and if 2 years 6 months to 3 years 6 months have passed since the date of randomization (visit 2) in the previous study.
Patients with stable COPD aged 40 years or older
Patients who meet the following criteria: post-bronchodilator FEV1/FVC < 0.7
Key exclusion criteria
Patients on oxygen therapy
Patients with clinically apparent asthma symptoms
Patients with a history of exacerbation of COPD within 3 months
Patients whose physical activity is extremely suppressed by diseases other than COPD (neuromuscular disease, severe osteoarthritis, active malignant tumor, acute myocardial infarction, etc.)
Patients who are judged by their doctor to be unable to participate in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Minakata |
Organization
NHO Wakayama Hospital
Division name
Department of Respiratory Medicine
Zip code
644-0044
Address
1138 Wada, Mihana-cho, Hidaka-gun, Wakayama
TEL
+81-738-22-3256
minakata.yoshiaki.qy@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Imoto |
Organization
NHO Wakayama Hospital
Division name
Corporate Planning Office
Zip code
644-0044
Address
1138 Wada, Mihama-cho, Hidaka-gun, Wakayama
TEL
+81-738-22-3256
Homepage URL
imoto.maki.nh@mail.hosp.go.jp
Sponsor or person
Institute
NHO Wakayama Hospital
Institute
Department
Personal name
Funding Source
Organization
Environmental Restoration and Conservation Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of NHO Wakayama Hospital
Address
1138 Wada, Mihama-cho, Hidaka-gun, Wakayama
Tel
+81-738-22-3256
inoue.atsuyuki.nx@mail.hosp.go.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
国立病院機構和歌山病院（和歌山県）
和歌山県立医科大学（和歌山県）
大阪公立大学（大阪府）
山口大学（山口県）
佐賀大学（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is a three-year follow-up study of patients enrolled in a previous study, "Effects of providing individual target step count for 6 months on the number of steps in patients with COPD (UMIN000046390)". Therefore, in this study, we will focus on patients who did not meet the exclusion criteria among the 73 cases analyzed in the previous study (38 cases in the group that received step count targets and 35 cases in the control group).
Management information
Registered date
| 2025 | Year | 01 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064801
