UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059708 |
|---|---|
| Receipt number | R000068294 |
| Scientific Title | Safety and Efficacy of Home-Based Respiratory Muscle Stretching Exercises Using Information and Communication Technology in Patients with Chronic Obstructive Pulmonary Disease:A Prospective Feasibility and Efficacy Study |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/10 00:36:49 |
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Basic information
Public title
Safety and Efficacy of Home-Based Respiratory Muscle Stretching Exercises Using Information and Communication Technology in Patients with Chronic Obstructive Pulmonary Disease
Acronym
ReSt-ICT Study
Scientific Title
Safety and Efficacy of Home-Based Respiratory Muscle Stretching Exercises Using Information and Communication Technology in Patients with Chronic Obstructive Pulmonary Disease:A Prospective Feasibility and Efficacy Study
Scientific Title:Acronym
ReSt-ICT Study (Respiratory Muscle Stretching via ICT Study)
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the implementation of ICT-supported home-based respiratory muscle stretching exercises for COPD patients before and after the intervention, evaluating its effectiveness (changes in CAT scores), safety (adverse events, readmissions, falls), and implementation rate. Furthermore, it will examine the feasibility and continuity of an ICT-supported program for patients who find outpatient rehabilitation difficult.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety (adverse events, readmissions, falls) and efficacy (change in COPD Assessment Test (CAT) score) at 8 weeks after initiation of rehabilitation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants performed respiratory muscle stretching exercises at home twice daily for 8 weeks using an instructional video. A smartwatch and tablet application were used to monitor step count, heart rate, and exercise adherence. Feedback and reminders were provided via chatbot. A follow-up outpatient visit was held at week 4, and reassessment was conducted at week 8.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Outpatient follow-up visits to the above medical departments
2.Aged 50 or older at the time of consent acquisition
3.Ability to walk independently (including with a cane)
4.Condition is stable with standard treatment.
5.Individuals with a COPD Assessment Test score of 10 or higher, or an mMRC grade of 2 or higher.
6.No history of COPD exacerbation within the past 3 months
7.Individuals who, after receiving sufficient explanation regarding participation in this study, provided written consent of their own free will based on full understanding
8.Individuals living with family members
Key exclusion criteria
1.Patients unable to walk independently or unable to undergo medical interviews or questionnaire administration
2.Patients with pacemakers (as the safety of digital devices like Fitbit cannot be guaranteed)
3.Patients with severe cerebrovascular disease, heart disease, respiratory disease, liver disease, kidney disease, digestive disease, or endocrine/metabolic disease
4.Patients with a life expectancy of less than one year due to malignant diseases, etc.
5.Patients with severe physical disabilities requiring long-term rehabilitation
6.Other individuals deemed unsuitable as research subjects by the principal investigator
7.Among the research subjects described in (1) above, eligibility is determined by satisfying all selection criteria in (2) and not meeting any exclusion criteria in (3).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Matsuno |
Organization
Juntendo University School of Medicine Affiliated Juntendo Tokyo Koto Geriatric Medical Center
Division name
Department of Respiratory medicine
Zip code
1360075
Address
Shinsuna 3-3-20, 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 School of Medicine Affiliated Juntendo Tokyo Koto Geriatric Medical Center
Division name
Department of Respiratory medicine
Zip code
1360075
Address
Shinsuna 3-3-20, 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
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, Juntendo University
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
Tel
0358021584
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
| 2025 | Year | 11 | Month | 10 | 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 | 11 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 05 | 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 | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068294
