UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029325 |
|---|---|
| Receipt number | 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 | 2020/03/30 19:27:47 |
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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
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
matsuo@h.jniosh.johas.go.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
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
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
Completed
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
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033518
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
