UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052922 |
|---|---|
| Receipt number | R000060386 |
| Scientific Title | Non-randomized controlled trials examining the effectiveness of online cardiac rehabilitation. |
| Date of disclosure of the study information | 2023/11/27 |
| Last modified on | 2023/11/27 20:46:37 |
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Basic information
Public title
Non-randomized controlled trials examining the effectiveness of online cardiac rehabilitation.
Acronym
Online cardiac rehabilitation study
Scientific Title
Non-randomized controlled trials examining the effectiveness of online cardiac rehabilitation.
Scientific Title:Acronym
Online cardiac rehabilitation study
Region
| Japan |
Condition
Condition
Cardio-vascular diseases
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to verify the effectiveness of online cardiac rehabilitation for cardiac patients who have started outpatient cardiac rehabilitation at Juntendo Hospital by connecting their homes to Juntendo University via the internet and providing exercise therapy while adjusting the intensity of exercise while monitoring in real time videos showing the subject, ECG, heart rate, oxygen saturation and other vital signs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise tolerance ( peak oxygen uptake) three months after the start of exercise.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
After checking the physical condition at the start of the exercise, the exercise on the bicycle ergometer is started. The exercise duration is set at 30 minutes, with a warm-up and cooling-down period before and after, in reference to the 'Guidelines for Rehabilitation in Cardiovascular Disease' of the Japanese Society of Cardiology. After the exercise, the subjective exercise intensity during the exercise and impressions about the exercise are entered and the exercise is completed. The exercise session is designed to last no longer than 60 minutes, including the physical condition check before the start of the exercise, the exercise on the bicycle ergometer (including warm-up and cooling-down) and the input of subjective exercise intensity and feedback on the exercise after the exercise. The session is guided to a session in which several people are connected online at the same time. In this case, patients cannot communicate with each other and cannot see each other's images or exercise status.
Interventions/Control_2
Outpatient cardiac 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Age between 20 and 90 years at the time of obtaining consent.
(ii) Patients who have been instructed by their physician to undergo cardiac rehabilitation and who have permission to exercise on a bicycle.
(iii) Patients who had no cardiovascular events during one month of outpatient cardiac rehabilitation.
(iv) Patients who have received a full explanation of their participation in the study, and who have given their free and voluntary written consent based on a full understanding of the study.
(v) In the online cardiac rehabilitation group, patients who have a family member who can cooperate during the implementation of exercise therapy.
Key exclusion criteria
(1) Those with neurological or muscular abnormalities that interfere with bicycle exercise.
(ii) Those with visual problems such as inability to see the screen of a tablet device.
(iii) Those with hearing problems such as inability to hear audio
(iv) Those who are otherwise deemed unsuitable as research subjects by the attending physician or principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
113-0033
Address
3-2-12 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN
TEL
+81-3-5802-0425
te-takahashi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
113-0033
Address
3-2-12 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN
TEL
+81-3-5802-0425
Homepage URL
te-takahashi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
KYOCERA Corporation
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
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN
Tel
03-5802-1584
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
| 2023 | Year | 11 | Month | 27 | 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
| 2023 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 11 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060386
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