UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049919 |
|---|---|
| Receipt number | R000056786 |
| Scientific Title | Creation of practical prediction equations for physical activity in COPD |
| Date of disclosure of the study information | 2023/01/04 |
| Last modified on | 2026/01/09 09:04:36 |
* 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
Creation of practical prediction equations for physical activity in COPD
Acronym
Prediction equations for physical activity in COPD
Scientific Title
Creation of practical prediction equations for physical activity in COPD
Scientific Title:Acronym
E-PAC
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To create the predictive equation of the indices of physical activity in patients with COPD.
Basic objectives2
Others
Basic objectives -Others
creating the predictive equation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prediction equation of step count
Key secondary outcomes
Prediction equation of the duration at 3.0 METs or higher
Prediction equation of the duration at 2.0 METs or higher
Prediction equation of the total activity at 3.0 METs or higher
Prediction equation of the duration at 1.0-1.5 METs
Validation of prediction equations in different cohort
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
post bronchodilator FEV1/FVC,0.7
40 years old or older
Key exclusion criteria
Patients with exacerbation within 3 months
Patients with severely restricted physical activity due to comorbidities
Patients receiving daytime oxygen therapy
Patients judged by the attending physician to be inappropriate for participation in this study
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Minakata |
Organization
National Hospital Organization Wakayama Hospital
Division name
Department of Respiratory Medicine
Zip code
644-0044
Address
1138 Wada, Mihama-cho, Hidaka-gun, Wakayama, Japan
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
National Hospital Organization Wakayama Hospital
Division name
Research secretariat
Zip code
644-0044
Address
1138 Wada, Mihama-cho, Hidaka-gun, Wakayama, Japan
TEL
+81-738-22-3256
Homepage URL
419-kenkyubu@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Wakayama Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo
Tel
+81-3-5712-5050
700-kenkyu@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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 04 | 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
394
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
| 2022 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 17 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 06 | Month | 30 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2022 | Year | 12 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056786
