UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062806 |
|---|---|
| Receipt number | R000071897 |
| Scientific Title | A Multicenter, Randomized, Open-label, Parallel-group Controlled Trial to Evaluate the Safety and Efficacy of Respiratory Muscle Stretching Exercise Combined with Remote Monitoring in Patients with Chronic Obstructive Pulmonary Disease (COPD) |
| Date of disclosure of the study information | 2026/09/07 |
| Last modified on | 2026/09/03 15:47:42 |
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Basic information
Public title
A study to evaluate the effects and safety of respiratory muscle stretching exercise with smartwatch-based remote monitoring in patients with COPD (chronic obstructive pulmonary disease)
Acronym
COPD Resipiratory muscle Stretch Study
Scientific Title
A Multicenter, Randomized, Open-label, Parallel-group Controlled Trial to Evaluate the Safety and Efficacy of Respiratory Muscle Stretching Exercise Combined with Remote Monitoring in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Scientific Title:Acronym
RMS-COPD(remote monitoring combined Respiratory Muscle Stretching trial for COPD)
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy, safety, and adherence of a home-based respiratory muscle stretching exercise program combined with ICT-based remote monitoring in patients with COPD, through a multicenter randomized controlled trial. This study also aims to clarify the feasibility and continuity of an ICT-based home pulmonary rehabilitation program for patients who have difficulty accessing outpatient-based pulmonary rehabilitation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[Safety] Incidence of adverse events, rehospitalization, and falls / [Efficacy] Change in COPD Assessment Test (CAT) score (between-group difference from baseline to the end of the 8-week intervention period)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group: After a 1-week wearable-only run-in period (remote monitoring of step count and heart rate via smartwatch, without exercise), participants perform respiratory muscle stretching exercise at home twice daily for 8 weeks, based on a video program developed by the principal investigator. Throughout the exercise period, step count, heart rate, and exercise adherence continue to be remotely monitored via smartwatch, and chatbot-based feedback messages are delivered via a provided tablet application to promote continued exercise and walking activity. A mid-point outpatient visit is conducted 4 weeks after exercise initiation to confirm adherence and provide guidance.
Interventions/Control_2
Control group: Participants continue usual care, without the respiratory muscle stretching program or wearable-based remote monitoring. Assessments (pulmonary function tests, questionnaires, etc.) are performed at baseline and at 8 weeks.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients regularly attending the relevant department at a participating institution
Aged 50 years or older at the time of consent
Diagnosed with COPD according to the Japanese Guideline for the Diagnosis and Treatment of COPD, 2022
Able to walk independently (with or without a cane)
Clinically stable on standard treatment
No history of COPD exacerbation within 3 months before enrollment
Provided written informed consent voluntarily after receiving a full explanation and understanding of the study
Key exclusion criteria
Unable to walk independently, or unable to complete interviews/questionnaires
Presence of a cardiac pacemaker (due to unconfirmed safety of the digital wearable device)
Severe cerebrovascular, cardiac, respiratory, hepatic, renal, gastrointestinal, or endocrine/metabolic disease
Life expectancy of less than 1 year due to malignancy or other conditions
Severe physical disability requiring long-term rehabilitation
Any other reason judged by the principal investigator to make the patient unsuitable for participation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Matsuno |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Department of Respiratory Medicine
Zip code
1360075
Address
3-3-20, Shinsuna, Koto-ku, Tokyo, Japan
TEL
0356323111
kmatsuno@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Matsuno |
Organization
Juntendo University
Division name
Department of Respiratory Medicine
Zip code
1360075
Address
3-3-20, Shinsuna, Koto-ku, Tokyo, Japan
TEL
0356323111
Homepage URL
kmatsuno@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Environmental Restoration and Conservation Agency (ERCA)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine
Address
Hongo2-1-1,Bunkyo-ku,Tokyo,Japan
Tel
03-5802-1584
hongo-rinri@juntendo.ac.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
| 2026 | Year | 09 | Month | 07 | 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
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071897
