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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029325
Receipt No. R000033518
Scientific Title New exercise program for patients with coronary heart disease
Date of disclosure of the study information 2017/10/01
Last modified on 2019/04/01

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Basic information
Public title New exercise program for patients with coronary heart disease
Acronym New exercise program for patients with coronary heart disease
Scientific Title New exercise program for patients with coronary heart disease
Scientific Title:Acronym New exercise program for patients with coronary heart disease
Region
Japan

Condition
Condition Coronary heart disease
Classification by specialty
Cardiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate availability of a new exercise program for a cardiac rehabilitation technique
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Peak oxygen consumption
Key secondary outcomes Cardiac function by echocardiogram /
blood pressure and biochemical assays of blood / thigh muscle thickness / autonomic nervous function / body fat / physical activity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 High-intensity interval aerobic training (10-13 min, 1-2 times/week, 3 months)
Interventions/Control_2 Moderate-intensity continuous aerobic training (30 min, 1-2 times/week, 3 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
40 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria Patients with ischemic heart disease / Patients who completes acute phase rehabilitations and needs recovery phase rehabilitations
Key exclusion criteria Exercise contraindications diagnosed by the primary doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Shigeru
Middle name
Last name Makita
Organization Saitama Medical University International Medical Center
Division name Department of Cardiac Rehabilitation
Zip code 3501298
Address 1397-1, Yamane, Hidaka, Saitama, Japan
TEL +81-42-984-4111
Email mshigeru-stm@umin.ac.jp

Public contact
Name of contact person
1st name Tomoaki
Middle name
Last name Matsuo
Organization National Institute of Occupational Safety and Health, Japan
Division name Occupational Epidemiology Research Group
Zip code 2148585
Address 6-21-1, Nagao, Tama-ku, Kawasaki, Kanagawa, Japan
TEL +81-44-865-6111
Homepage URL
Email matsuo@h.jniosh.johas.go.jp

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

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

IRB Contact (For public release)
Organization Saitama medical university international medical center IRB
Address 1397-1, Yamane, Hidaka, Saitama, Japan
Tel +81-42-984-4523
Email chikens@saitama-med.ac.jp

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 埼玉医科大学国際医療センター(埼玉県)
Saitama Medical University International Medical Center

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 24 Day
Date of IRB
2017 Year 03 Month 13 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2020 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
2017 Year 09 Month 28 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033518

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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