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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027866
Receipt No. R000031787
Scientific Title A Study of the Effect Between Interval Training and Endurance Exercise on Heart Disease Patients
Date of disclosure of the study information 2017/06/23
Last modified on 2017/06/22

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Basic information
Public title A Study of the Effect Between Interval Training and Endurance Exercise on Heart Disease Patients
Acronym INDEED study
Scientific Title A Study of the Effect Between Interval Training and Endurance Exercise on Heart Disease Patients
Scientific Title:Acronym INDEED study
Region
Japan

Condition
Condition Cardiac patients
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparing the effectiveness of interval training with endurance exercise for cardiac patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Exercise tolerance measured during cardiopulmonary exercise testing.
Key secondary outcomes Measurement of the amount and percentage change from the baseline to each observation point for the following parameters:
1. Echocardiography
2. Cardiac MRI
3. Vital signs and general blood/urine tests
4. Special blood/urine tests
5. The ratio of continuous outpatients rehabilitation.
6. Various muscle strength

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Group A: Administer interval training
Interval training is administered and continued for 5 months.
Interventions/Control_2 Group B: Administer endurance training
Endurance training is administered and continued for 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cardiac patients who are selected for cardiac rehabilitation.
Key exclusion criteria Patients who fall into one or more of the following criteria are excluded from participating in the study.
1. Patients with advanced dementia.
2. Patients who have difficulties to continue interval training (cerebrovascular diseases such as hemiplegia etc.)
3. Patients who are assessed to be inappropriate for the study by study investigators.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taisuke Nakade
Organization Gunma Prefectural Cardiovascular Center
Division name Department of Cardiology
Zip code
Address 3-12 Kameizumi, Maebashi, Gunma
TEL 027-269-7455
Email t.nakade.gcvc@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Taisuke Nakade
Organization Gunma Prefectural Cardiovascular Center
Division name Department of Cardiology
Zip code
Address 3-12 Kameizumi, Maebashi, Gunma
TEL 027-269-7455
Homepage URL
Email t.nakade.gcvc@gmail.com

Sponsor
Institute Gunma Prefectural Cardiovascular Center
Institute
Department

Funding Source
Organization No funding source
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2017 Year 06 Month 23 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2017 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 19 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
2017 Year 06 Month 22 Day
Last modified on
2017 Year 06 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031787

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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