UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040657 |
|---|---|
| Receipt number | R000046406 |
| Scientific Title | Home-based real-time cardiac telerehabilitation: a randomized controlled non-inferiority trial |
| Date of disclosure of the study information | 2020/06/05 |
| Last modified on | 2021/06/06 09:03:16 |
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Basic information
Public title
Home-based real-time cardiac telerehabilitation: a randomized controlled non-inferiority trial
Acronym
Home-based real-time cardiac telerehabilitation: a randomized controlled non-inferiority trial
Scientific Title
Home-based real-time cardiac telerehabilitation: a randomized controlled non-inferiority trial
Scientific Title:Acronym
Home-based real-time cardiac telerehabilitation: a randomized controlled non-inferiority trial
Region
| Japan |
Condition
Condition
heart disease
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the safety and efficacy of home-based real-time remotely monitored cardiac telerehabilitation with center-based outpatient cardiac rehabilitation program among patients with cardiovascular disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
peak oxygen uptake
Key secondary outcomes
cardiac event duding exercise and fall
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Supervised exercise training twice weekly for 4-week at the hospital and supervised real-time tele rehabilitation twice weekly 8-week at home.
Interventions/Control_2
Patients continue supervised exercise training twice weekly for 12-week at hospital.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients provided signed informed consent to participate in the study, and have internet access at home
Key exclusion criteria
Patients with absolute contraindications to cardiac rehabilitation, could not exercise using cycle ergometer caused by severe functional decline or disability
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Saitoh |
Organization
Sakakibara Heart Institute
Division name
Department of Rehabilitation
Zip code
1830003
Address
3-16-1. Asahi-cho, Fuchu, Tokyo
TEL
042-313-3111
msaitoh@shi.heart.or.jp
Public contact
Name of contact person
| 1st name | Kanae |
| Middle name | |
| Last name | Asami |
Organization
Sakakibara Heart Institute
Division name
Department of clinical reserch support
Zip code
1830003
Address
3-16-1. Asahi-cho, Fuchu, Tokyo
TEL
042-313-3111
Homepage URL
hij-p@shi.heart.or.jp
Sponsor or person
Institute
Sakakibara Heart Institute
Institute
Department
Personal name
Funding Source
Organization
The Japanese Association of Cardiac Rehabilitation
Japan Heart Club
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sakakibara Heart Institute
Address
3-16-1. Asahi-cho, Fuchu, Tokyo
Tel
042-314-3111
hij-p@shi.heart.or.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
| 2020 | Year | 06 | Month | 05 | 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
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | 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 | 06 | Month | 05 | Day |
Last modified on
| 2021 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046406
