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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040657
Receipt No. 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

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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
Email 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
Email hij-p@shi.heart.or.jp

Sponsor
Institute Sakakibara Heart Institute
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046406

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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