UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034791 |
|---|---|
| Receipt number | 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 20:19:27 |
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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
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
yarukimanmann2000@yahoo.co.jp
Sponsor or person
Institute
Gunma Prefectural Cardiovasuclar Center
Depertment of Cardiology
3-12, Kameizumi-Kou,Maebashi.Gunma
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039676
