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
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
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
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
