UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047281 |
|---|---|
| Receipt number | R000053914 |
| Scientific Title | Study on the validity of a formula for predicting the number of steps taken by COPD patients |
| Date of disclosure of the study information | 2022/03/26 |
| Last modified on | 2025/03/27 18:36:23 |
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Basic information
Public title
Study on the validity of a formula for predicting the number of steps taken by COPD patients
Acronym
Study of predicting the number of steps taken by COPD patients
Scientific Title
Study on the validity of a formula for predicting the number of steps taken by COPD patients
Scientific Title:Acronym
Study of predicting the number of steps taken by COPD patients
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will develop a precise prediction equation for the daily number of steps taken by Japanese COPD patients using a number of indices, and will examine whether the previously proposed simple prediction equation can be validated in another cohort population, and whether it can be correlated with the values derived from the precise prediction equation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of the validity of a simple prediction formula in COPD patients
Key secondary outcomes
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
COPD patients with FEV1/FVC <70% after bronchodilator therapy.
Key exclusion criteria
1.Clinically evident bronchial asthma patients.
2.Patients on oxygen therapy
3.Patients with a history of lung resection
4.Patients with a history of COPD exacerbation within 3 months
5.Patients whose physical activity is severely inhibited by diseases other than COPD.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Azuma |
Organization
National Hospital Organization Wakayama Hospital
Division name
Respiratory Medicine
Zip code
644-0044
Address
1138 Wada, Mihama-cho, Hidaka-gun, Wakayama
TEL
0738223256
azuma19841025@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Azuma |
Organization
National Hospital Organization Wakayama Hospital
Division name
Respiratory Medicine
Zip code
644-0044
Address
1138 Wada, Mihama-cho, Hidaka-gun, Wakayama
TEL
0738223256
Homepage URL
azuma19841025@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Wakayama Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
National Hospital Organization Wakayama Hospital
Address
1138 Wada, Mihama-cho, Hidaka-gun, Wakayama
Tel
0738223256
minami.koichi.mc@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
| 2022 | Year | 03 | Month | 26 | 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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
We developed a simple prediction equation for the number of daily steps taken by Japanese COPD patients using three indices: age, mMRC dyspnea scale, and IC. We also examined the use of more indices and developed a precise prediction equation for the number of steps taken using four indices: 6MWD, mMRC, HADS-A, and FEV1 %pred. In this study, we will examine the validity of the simple prediction equation in a different cohort population, and also examine the correlation between the values of the simple prediction equation and those of the precise prediction equation to verify the validity of the simple prediction equation.
Management information
Registered date
| 2022 | Year | 03 | Month | 25 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053914
