UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055832 |
|---|---|
| Receipt number | R000063812 |
| Scientific Title | Effectiveness of pulmonary telerehabilitation in preventing rehospitalization for patients with chronic respiratory disease: a prospective cohort study |
| Date of disclosure of the study information | 2024/10/15 |
| Last modified on | 2025/07/14 11:35:03 |
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Basic information
Public title
Development of pulmonary telerehabilitation for early social implementation and evaluation of its effectiveness in preventing rehospitalization
Acronym
Effectiveness of pulmonary telerehabilitation in preventing rehospitalization
Scientific Title
Effectiveness of pulmonary telerehabilitation in preventing rehospitalization for patients with chronic respiratory disease: a prospective cohort study
Scientific Title:Acronym
Effectiveness of pulmonary rehabilitation in preventing rehospitalization for patients with chronic respiratory disease
Region
| Japan |
Condition
Condition
Chronic respiratory diseases
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a minimal-resource system for pulmonary telerehabilitation (PTR) based on information and communication technology (ICT), utilizing the patient's residential environment without the need for specialized exercise therapy equipment. The effectiveness of this system will be evaluated in terms of its ability to prevent rehospitalization.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
All-cause readmission within 90 days of discharge
Key secondary outcomes
Lower limb muscle strength (30-second chair standing test)
Physical activity (average number of steps per day, duration of activity by intensity)
Health-related quality of life (COPD Assessment Test, St.Geoge's Respiratory Questionnaire)
Anxiety and Depression (Hospital Anxiety and Depression Scale)
PTR implementation status (number of times the program was implemented, rehabilitation interruptions and their reasons)
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
| Behavior,custom |
Interventions/Control_1
The following respiratory rehabilitation protocol, which utilizes the patient's home environment as a resource, will be implemented in a format adapted for PTR. Duration: 40-60 minutes per session, frequency: 2 sessions per week, duration: 13 weeks. Program: The physical therapist will monitor the following exercises through the screen of the patient's tablet device: breathing exercises, chair rise exercises, calf raises, half squats, upper limb raising exercises, and physical activity guidance.
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those deemed eligible for post-discharge pulmonary rehabilitation by a physician
Those who can sufficiently understand how to use the remote system equipment
For those with hearing impairments or who cannot fully understand how to use the equipment, a family member who can assist with the implementation of PTR is required
Key exclusion criteria
Severe physical frailty (Japanese version of the Clinical Frailty Scale > 6)
Sserious comorbidities (e.g., pulmonary hypertension, malignant tumors)
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Suyama |
Organization
Reiwa Health Sciences University
Nagasaki University Graduate School of Biomedical Sciences
Division name
Faculty of Rehabilitation
Zip code
811-0213
Address
2-1-12 Wajirogaoka, Higashi-ku, Fukuoka City, Fukuoka Prefecture, Japan
TEL
092-607-6701
kazuaki.suyama@rhs-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Suyama |
Organization
Reiwa Health Sciences University
Division name
Faculty of Rehabilitation
Zip code
811-0213
Address
2-1-12 Wajirogaoka, Higashi-ku, Fukuoka City, Fukuoka Prefecture, Japan
TEL
092-607-6701
Homepage URL
kazuaki.suyama@rhs-u.ac.jp
Sponsor or person
Institute
Reiwa Health Sciences University
Institute
Department
Personal name
Kazuaki Suyama
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nagasaki University Graduate School of Biomedical Sciences, Tagami Hospital, Inoue Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Reiwa Health Sciences University Ethics Committee
Address
2-1-12 Wajirogaoka, Higashi-ku, Fukuoka City, Fukuoka Prefecture, Japan
Tel
092-607-6706
krinri@rhs-u.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
田上病院（長崎県）、井上病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063812
