UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059402 |
|---|---|
| Receipt number | R000067769 |
| Scientific Title | Verification of the Efficacy of a Message App Intervention to Improve Physical Activity in Outpatients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/10/20 |
| Last modified on | 2025/10/14 22:48:49 |
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Basic information
Public title
Verification of the Efficacy of a Message App Intervention to Improve Physical Activity in Outpatients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Acronym
Verification of the Efficacy of a Message App Intervention to Improve Physical Activity in Outpatients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Scientific Title
Verification of the Efficacy of a Message App Intervention to Improve Physical Activity in Outpatients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Scientific Title:Acronym
Verification of the Efficacy of a Message App Intervention to Improve 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 physical activity can be improved by using a widely popular messaging app among Japanese people to regularly and conveniently encourage physical activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Average daily walking time, Average daily step count
Key secondary outcomes
Lower limb muscle strength,COPD Assessment Test,Modified Medical Research Council Dyspnea Scale,Peak Work Rate,Exercise phobia
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 | Maneuver |
Interventions/Control_1
The control group will receive the usual guidance to encourage physical activity.
Interventions/Control_2
The intervention group will receive messages twice weekly in the morning instructing them to set their own physical activity goals.
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
(4) Individuals who use a messaging app
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 unable to provide informed consent for the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Suenaga |
Organization
Kato Clinic of Internal Medicine and Pulmonology
Division name
Rehabilitation Room
Zip code
8490506
Address
29-12 Suetsugi, Honjo-machi, Saga City, Saga Prefecture 840-0024 Japan
TEL
08039608107
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
0952-20-8822
Homepage URL
susantokumei@gmail.com
Sponsor or person
Institute
Other
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
0952-20-8822
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
Institutions
Institutions
かとうクリニック内科・呼吸器内科（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | 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
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
Date trial data considered complete
Date analysis concluded
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=R000067769
