UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058893 |
|---|---|
| Receipt number | R000067353 |
| Scientific Title | An Exploratory Study on the Feasibility of a Pulmonary Tele-rehabilitation System for Supporting Self-Management in Patients with Chronic Obstructive Pulmonary Disease |
| Date of disclosure of the study information | 2025/08/25 |
| Last modified on | 2025/08/25 18:30:01 |
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Basic information
Public title
An Exploratory Study on the Feasibility of a Pulmonary Tele-rehabilitation System for Supporting Self-Management in Patients with Chronic Obstructive Pulmonary Disease
Acronym
A Study on the Feasibility of Pulmonary Telerehabilitation in Patients with Chronic Obstructive Pulmonary Disease
Scientific Title
An Exploratory Study on the Feasibility of a Pulmonary Tele-rehabilitation System for Supporting Self-Management in Patients with Chronic Obstructive Pulmonary Disease
Scientific Title:Acronym
A Study on the Feasibility of Pulmonary Telerehabilitation in Patients with Chronic Obstructive Pulmonary Disease
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the short-term effects of pulmonary tele-rehabilitation on physical activity levels and health-related quality of life (HRQOL) in patients with chronic obstructive pulmonary disease (COPD), as well as to evaluate their adherence to the system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of life assessment using the Japanese version of the St. George's Respiratory Questionnaire (SGRQ)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Pulmonary tele-rehabilitation will be conducted four times in total, approximately once every two weeks (40 minutes per session), with the schedule adjusted to accommodate each participant's availability.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
GOLD stage II or higher according to the COPD guidelines of the Japanese Respiratory Society
Key exclusion criteria
Individuals who have received pulmonary rehabilitation within the past six months
Individuals who have been hospitalized within the past three months
Individuals diagnosed with dementia
Individuals with visual impairments that prevent them from viewing a tablet screen
Individuals with hearing impairments that prevent them from hearing audio content
Individuals deemed unsuitable for study participation by the principal investigator for any other reason
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Sano |
Organization
Graduate School of Health Care and Nursing, Juntendo University
Division name
Clinical Research Unit
Zip code
279-0023
Address
2-5-1, Takasu, Urayasu City, Chiba
TEL
0473553111
yu-sano@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | JUN |
| Middle name | |
| Last name | UEKI |
Organization
Graduate School of Health Care and Nursing, Juntendo University
Division name
Clinical Research Unit
Zip code
279-0023
Address
2-5-1, Takasu, Urayasu City, Chiba
TEL
0473553111
Homepage URL
junueki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Fukuda Denshi Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Juntendo University
Address
2-1-1 Hongo Bunkyo-Ku Tokyo
Tel
03-3813-3111
N/A
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 | 08 | Month | 25 | 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
| 2024 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2026 | 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 | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067353
