UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058987 |
|---|---|
| Receipt number | R000067237 |
| Scientific Title | A prospective intervention study to clarify the effects of asynchronous remote exercise therapy for patients with chronic respiratory diseases |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/04 09:57:42 |
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Basic information
Public title
Elucidation of the effects of asynchronous remote exercise therapy on patients with chronic respiratory diseases
Acronym
efficacy of remote exercise therapy for patients with chronic respiratory diseases
Scientific Title
A prospective intervention study to clarify the effects of asynchronous remote exercise therapy for patients with chronic respiratory diseases
Scientific Title:Acronym
ReMOTE-CRD study
Region
| Japan |
Condition
Condition
Chronic respiratory diseases
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are twofold: To determine whether chronic respiratory disease patients who use asynchronous telerehabilitation at home can improve their physical function and health-related quality of life (HRQOL), and To determine whether continued asynchronous telerehabilitation can maintain the effects of improved exercise tolerance and HRQOL over the long term.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
6-minute walking distance
Key secondary outcomes
6-minute walk test, quadriceps muscle strength, grip strength, dyspnea, health-related quality of life, activities of daily living, anxiety and depression, satisfaction survey, pulmonary function tests
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the intervention group, exercise therapy that can be performed at home, such as aerobic exercise and muscle strengthening exercises, will be prescribed by Recaval and instructed to the patients. Patients will visit the clinic approximately once every 4-5 weeks, at which time the assigned physical therapist will confirm the implementation of the exercise therapy and adjust the exercise load.The exercise load is determined based on the initial assessment results and set to maintain a modified Borg scale of 3-5. The implementation status can be checked online by the assigned physical therapist. Once a week, a reminder and empowerment message is sent via chat function by the physician or physical therapist.
Interventions/Control_2
The control group will continue their usual medical care until their next visit.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients diagnosed with COPD or IIPs and currently receiving outpatient care at the Department of Respiratory Medicine at Toyo University Medical Center Oomori Hospital or Yokocho Hospital
2.Patients aged 40 years or older at the time of consent acquisition
3.Patients who are able to walk independently
4.Patients whom a physician determines are capable of undergoing accurate pulmonary function tests and walking tests
5.Patients whose condition is stable and have not undergone any changes in treatment for over three months
6.Individuals who own a smartphone, tablet, or computer and are deemed capable of using this service
7.Patients who have received adequate explanation of the study content and have provided written informed consent
8.Patients currently enrolled in or who have completed an outpatient rehabilitation program, with stable symptoms, and who do not have an outpatient rehabilitation program scheduled during the course of this trial
Key exclusion criteria
1.Patients with severe orthopedic or central nervous system disorders requiring assistance in daily living
2.Patients with a history of hospitalization within the past 6 months due to worsening of the underlying disease
3.Patients with unstable heart disease
4.Other patients for whom participation in this clinical study may compromise patient safety, or patients for whom compliance with the clinical study protocol is deemed difficult.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Soh |
| Middle name | |
| Last name | Imamura |
Organization
SBC Tokyo Medical University
Division name
Department of Physical Therapy, Faculty of Health Care Sciences
Zip code
279-8567
Address
5-8-1 Akemi, Urayasu-shi, Chiba, Japan
TEL
047-382-2111
s-imamura@sbctmu.ac.jp
Public contact
Name of contact person
| 1st name | Soh |
| Middle name | |
| Last name | Imamura |
Organization
SBC Tokyo Medical University
Division name
Department of Physical Therapy, Faculty of Health Care Sciences
Zip code
279-8567
Address
5-8-1 Akemi, Urayasu-shi, Chiba, Japan
TEL
047-382-2111
Homepage URL
s-imamura@sbctmu.ac.jp
Sponsor or person
Institute
SBC Tokyo Medical University
Institute
Department
Personal name
Soh Imamura
Funding Source
Organization
SBC Tokyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Toho University Medical Center Omori Hospital, Kanamecho Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SBC Tokyo Medical University
Address
5-8-1 Akemi, Urayasu-shi, Chiba, 279-0014, Japan
Tel
047-382-2111
s-imamura@sbctmu.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
千葉県
Institutions
Institutions
東邦大学医療センター大森病院（東京都）、医療法人社団愛語会 要町病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 01 | 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 | 08 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 20 | 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
| 2025 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067237
