UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059403 |
|---|---|
| Receipt number | R000067767 |
| Scientific Title | Evaluation of the Effectiveness of Physical Activity Guidance for Outpatients with Chronic Obstructive Pulmonary Disease |
| Date of disclosure of the study information | 2025/10/16 |
| Last modified on | 2025/10/14 23:08:03 |
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Basic information
Public title
Evaluation of the Effectiveness of Physical Activity Guidance for Outpatients with Chronic Obstructive Pulmonary Disease
Acronym
Evaluation of the Effectiveness of Physical Activity Guidance for Outpatients with Chronic Obstructive Pulmonary Disease
Scientific Title
Evaluation of the Effectiveness of Physical Activity Guidance for Outpatients with Chronic Obstructive Pulmonary Disease
Scientific Title:Acronym
Effect of Guidance on Improving Physical Activity in Outpatients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines whether walking time or step count is more effective in improving physical activity levels through exercise guidance for patients with chronic obstructive pulmonary disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Average daily walking time, average daily step count
Key secondary outcomes
Lower limb muscle strength,Exercise phobia,Modified Medical Research Council scale,COPD Assessment Test,Peak Work Rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
For both the walking time group and the step count group, explain the goal-setting method and the log. Patients determine their own goals to encourage physical activity.
Interventions/Control_2
After instruction, reassess physical activity for one month.
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) Patients in a stable condition with a Mini Mental State Examination (MMSE) score of 24 or higher
(2) No gender restrictions
(3) Outpatients
Key exclusion criteria
(1) Individuals with severe medical complications other than chronic respiratory failure
(2) Individuals whose mobility, such as walking, is impaired due to physical disability
(3) Individuals within one month of an acute exacerbation of chronic respiratory failure
(4) Individuals with significant dementia
(5) Other individuals deemed unsuitable as subjects by the attending physician
(6) Individuals for whom research consent cannot be obtained
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Suenaga |
Organization
Kato Clinic Internal Medicine and Respiratory Medicine
Division name
Rehabilitation Room
Zip code
8400024
Address
29-12 Suetsugi, Honjo-machi, Saga City, Saga Prefecture 840-0024 Japan
TEL
0952-20-8822
susantokumei@gmail.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Suenaga |
Organization
Kato Clinic Internal Medicine and Respiratory Medicine
Division name
Rehabilitation Room
Zip code
8490506
Address
29-12 Suetsugi, Honjo-machi, Saga City, Saga Prefecture 840-0024 Japan
TEL
08039608107
Homepage URL
susantokumei@gmail.com
Sponsor or person
Institute
Kato Clinic Internal Medicine and Respiratory Medicine
Institute
Department
Personal name
Takuya Suenaga
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kato Clinic Internal Medicine and Respiratory Medicine
Address
29-12 Suetsugi, Honjo-machi, Saga City, Saga Prefecture 840-0024 Japan
Tel
08039608107
susantokumei@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
上小田1150
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067767
