UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060146 |
|---|---|
| Receipt number | R000068791 |
| Scientific Title | A Multicenter Observational Study of Long-term Changes in Physical Activity and Sedentary Behavior and Associated Factors in Patients with Chronic Obstructive Pulmonary Disease |
| Date of disclosure of the study information | 2025/12/20 |
| Last modified on | 2025/12/20 15:22:12 |
* 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
A Multicenter Observational Study of Long-term Changes in Physical Activity and Sedentary Behavior and Associated Factors in Patients with Chronic Obstructive Pulmonary Disease
Acronym
A Multicenter Observational Study of Long-term Changes in Physical Activity and Sedentary Behavior and Associated Factors in Patients with Chronic Obstructive Pulmonary Disease
Scientific Title
A Multicenter Observational Study of Long-term Changes in Physical Activity and Sedentary Behavior and Associated Factors in Patients with Chronic Obstructive Pulmonary Disease
Scientific Title:Acronym
A Multicenter Observational Study of Long-term Changes in Physical Activity and Sedentary Behavior and Associated Factors in Patients with Chronic Obstructive Pulmonary Disease
Region
| Japan |
Condition
Condition
Chronic Obtructice Pulmonary Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the background factors associated with long-term changes in physical activity and sedentary behavior in patients with COPD.
Basic objectives2
Others
Basic objectives -Others
The objective of this study is to investigate the factors associated with longitudinal changes in physical activity and sedentary behavior in patients with COPD, by retrospectively comparing data from the same participants who enrolled in two prospective studies.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of factors associated with longitudinal changes in daily step count.
Key secondary outcomes
Longitudinal changes in active duration at >=3 METs
Longitudinal changes in sedentary duration at 1.0-1.5 METs
Identification of factors associated with longitudinal changes in total physical activity (MET-hours)
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
1. Stable outpatients with COPD.
2. Aged 40 years or older.
3. Post-bronchodilator FEV1/FVC ratio < 70%.
Key exclusion criteria
1. Patients with a COPD exacerbation within the past 3 months
2. Patients whose physical activity is severely limited due to comorbidities
3. Patients receiving home oxygen therapy
4. Patients judged by the investigator or sub-investigator to be unsuitable for participation in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Murakami |
Organization
NHO Wakayama Hospital
Division name
Department of Respiratory Medicine
Zip code
644-0044
Address
1138 Wada, Mihama-cho, Hidaka-gun, Wakayama
TEL
0738-22-3256
murakamiy0606@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Murakami |
Organization
NHO Wakayama Hospital
Division name
Department of Respiratory Medicine
Zip code
644-0044
Address
1138 Wada, Mihama-cho, Hidaka-gun, Wakayama
TEL
0738-22-3256
Homepage URL
murakamiy0606@yahoo.co.jp
Sponsor or person
Institute
NHO Wakayama Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Headquarters
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
NHO Wakayama Hospital
Address
1138 Wada, Mihama-cho, Hidaka-gun, Wakayama
Tel
0738-22-3256
murakamiy0606@yahoo.co.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
| 2025 | Year | 12 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective cohort study. We will analyze and compare accelerometer data from identical patients who participated in both the SPACE study (UMIN000025459) and the E-PAC study (UMIN000049919). The analysis aims to identify background factors from the initial study (SPACE) that are associated with the longitudinal changes in physical activity data between the two studies.
Management information
Registered date
| 2025 | Year | 12 | Month | 20 | Day |
Last modified on
| 2025 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068791
