UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009935
Receipt number R000011641
Scientific Title The effect of internet-based cardiac rehabilitation on improving coronary risk factors: A randomized controlled trial.
Date of disclosure of the study information 2013/02/02
Last modified on 2014/04/08 21:04:47

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Basic information

Public title

The effect of internet-based cardiac rehabilitation on improving coronary risk factors: A randomized controlled trial.

Acronym

The effect of internet-based cardiac rehabilitation on improving coronary risk factors: A randomized controlled trial.

Scientific Title

The effect of internet-based cardiac rehabilitation on improving coronary risk factors: A randomized controlled trial.

Scientific Title:Acronym

The effect of internet-based cardiac rehabilitation on improving coronary risk factors: A randomized controlled trial.

Region

Japan


Condition

Condition

Patients with ischemic heart disease

Classification by specialty

Cardiology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of internet-based cardiac rehabilitation on improving coronary risk factors

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Coronary risk factors (HDL, LDL, Triglyceride, Home based blood pressure, HbA1c, Fasting blood glucose and BMI)

Key secondary outcomes

Exercise capacity and Physical activity,


Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

1.Support the lifestyle modification for secondary prevention via internet
2.Self-monitoring exercise by using the pulse monitoring device

Period of intervention: 12 weeks

Interventions/Control_2

Outpatient follow up

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patient with NYHA classification I to II
2.Patient without congested heart failure
3.Patient without ischemic symptom at rest or exercise at less than 16 ml/min/kg
4.Patient without fatal arrhythmia
5.Patient has the self-management ability

Key exclusion criteria

1.Patient with inaccessible to computers
2.Patient with chronic atrial fibrillation
3.Patient with orthopedic or neurogenic disorders and cognitive impairment.
4.Patient receives hemodialysis

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name YAMADA SUMIO

Organization

Nagoya University

Division name

Graduate School of Medicine

Zip code


Address

Daikominami 1-1-20 Higashi-ku Nagioya

TEL

052-719-1346

Email

yamadas@met.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name YAMADA SUMIO

Organization

Nagoya University

Division name

Graduate School of Medicine

Zip code


Address

Daikominami 1-1-20 Higashi-ku Nagioya

TEL

052-719-1346

Homepage URL


Email

yamadas@met.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

SEIKO EPSON CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2013 Year 02 Month 02 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

Terminated

Date of protocol fixation

2013 Year 01 Month 09 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 01 Day

Last follow-up date

2014 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

2013 Year 02 Month 02 Day

Last modified on

2014 Year 04 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011641


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name