UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study of the Effect Between Interval Training and Endurance Exercise on Heart Disease Patients
Title of the study (Brief title)	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	Taisuke Nakade
Organization	Gunma Prefectural Cardiovascular Center
Division name	Department of Cardiology
Address	3-12 Kameizumi, Maebashi, Gunma
TEL	027-269-7455
Email	t.nakade.gcvc@gmail.com

Public contact
Name of contact person	Taisuke Nakade
Organization	Gunma Prefectural Cardiovascular Center
Division name	Department of Cardiology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031787