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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034791
Receipt No. R000039676
Scientific Title Efficacy of the cycle ergometer with the electrical stimulator (Knee trainer) for autonomic nerve system in patients with heart disease
Date of disclosure of the study information 2018/11/12
Last modified on 2018/11/06

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Basic information
Public title Efficacy of the cycle ergometer with the electrical stimulator (Knee trainer) for autonomic nerve system in patients with heart disease
Acronym Certi-auto study
Scientific Title Efficacy of the cycle ergometer with the electrical stimulator (Knee trainer) for autonomic nerve system in patients with heart disease
Scientific Title:Acronym Certi-auto study
Region
Japan

Condition
Condition Heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate that the exercise prescription of anaerobic threshold (AT) ergometer with Knee trainer improves autonomic nerve system than that of AT ergometer during 5 months in cardiac rehabilitation program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Increase absorute value and improvement rate of delta heart rate/delta work rate.
Key secondary outcomes Increase relative value and improvement rate of delta heart rate/delta work rate, Increase absolute or relative values, and improvement delta heart rate/delta VO2. Decrase absolute and relative values, and improvement of heart rate at rest

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
Maneuver
Interventions/Control_1 Exercise prescription of anaearobic threshold (AT) ergometer with Knee trainer vs exercise prescription of AT ergometer
Interventions/Control_2 Exercise therapy 2 to 3 times per week,5 months
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Heart disease
Key exclusion criteria Patient with heart disease without stable condition
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Murata Makoto
Organization Gunma Prefectural Cardiovasuclar Center
Division name Depertment of Cardiology
Zip code
Address 3-12, Kameizumi-Kou,Maebashi.Gunma
TEL +81272697455
Email yarukimanmann2000@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Murata Makoto
Organization Gunma Prefectural Cardiovasuclar Center
Division name Depertment of Cardiology
Zip code
Address 3-12, Kameizumi-Kou,Maebashi.Gunma
TEL +81272697455
Homepage URL
Email yarukimanmann2000@yahoo.co.jp

Sponsor
Institute Gunma Prefectural Cardiovasuclar Center
Depertment of Cardiology
3-12, Kameizumi-Kou,Maebashi.Gunma
Institute
Department

Funding Source
Organization Panasonic
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
2018 Year 11 Month 12 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 06 Day
Last modified on
2018 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039676

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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