UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027866 |
|---|---|
| Receipt number | 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 13:17:06 |
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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
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
t.nakade.gcvc@gmail.com
Sponsor or person
Institute
Gunma Prefectural Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031787
