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

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 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

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

Value
https://center6.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