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

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 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


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

Value
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