UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of the cycle ergometer with the electrical stimulator (Knee trainer) for ventilatory efficiency in patients with heart disease (Certi-vent study)
Title of the study (Brief title)	Certi-vent 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 decreases VE vs VCO2 slope 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	Decrease absolute value of VE vs VCO2 slope
Key secondary outcomes	Decrease relative value and improvement rate of VE vs VCO2 slope. Decrease absolute or relative values, and improvement rate of minimum VE/VCO2, Increase absolute or relative values, and improvement rate of minimum TV/RR ratio.

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	Murata Makoto
Organization	Gunma Prefectural Cardiovascular Center
Division name	Depertment of Cardiology
Address	3-12, Kameizumi-Kou,Maebashi.Gunma
TEL	+81272697455
Email	yarukimanmann2000@yahoo.co.jp

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

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

Funding Source
Organization	Panasonic
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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=R000039674