UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042022 |
|---|---|
| Receipt number | R000047805 |
| Scientific Title | Effect of pulmonary tele-rehabilitation in patients with COPD: a randomized controlled trial. |
| Date of disclosure of the study information | 2020/10/06 |
| Last modified on | 2025/04/10 13:09:56 |
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Basic information
Public title
Effect of pulmonary tele-rehabilitation in patients with COPD
Acronym
Effect of pulmonary tele-rehabilitation in patients with COPD
Scientific Title
Effect of pulmonary tele-rehabilitation in patients with COPD: a randomized controlled trial.
Scientific Title:Acronym
Effect of pulmonary tele-rehabilitation in patients with COPD: a randomized controlled trial.
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of pulmonary tele-rehabilitation compared with centre based pulmonary rehabilitation in patiens with COPD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incremental Shuttle Walking Test (ISWT)
Key secondary outcomes
cardiopulmonary exercise test (CPET), daily step count, COPD Assessment Test (CAT), Hospital Anxiety and Depression Scale (HADS), program sessions, acute exacerbation / hospitalization, Client Satisfaction Questionnaire-8 (CSQ-8)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
pulmonary tele-rehabilitation
Interventions/Control_2
centre based pulmonary rehabilitation
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases decided by a doctor to be indicated for pulmonary rehabilitation
Cases who can obtain a sufficient understanding of how to use the equipment of the tele-rehabilitation system by themselves or their housemates
Key exclusion criteria
Hospitalized due to exacerbation of respiratory failure within the past 4 weeks
Have a any serious comorbidities (eg, pulmonary hypertension, malignant tumor)
Target sample size
46
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
Other related organizations
Co-sponsor
Tagami Hospital, Inoue Hospital, Integrity Healthcare Inc.
Name of secondary funder(s)
Philips Japan Inc.
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
| 2020 | Year | 10 | Month | 06 | 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
| 2020 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | 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
| 2020 | Year | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047805
