UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024723
Receipt number R000027651
Scientific Title Maintenance of Exercise After Phase II Cardiac Rehabilitation using a novel motion-sensing system
Date of disclosure of the study information 2016/11/05
Last modified on 2022/11/10 15:20:45

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Basic information

Public title

Maintenance of Exercise After Phase II Cardiac Rehabilitation using a novel motion-sensing system

Acronym

Phase III Cardiac Rehabilitation using a novel motion-sensing system

Scientific Title

Maintenance of Exercise After Phase II Cardiac Rehabilitation using a novel motion-sensing system

Scientific Title:Acronym

Phase III Cardiac Rehabilitation using a novel motion-sensing system

Region

Japan


Condition

Condition

patients with cardiovascular diseases at phase III cardiac rehabilitation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of exercise program using a novel activity-promoting gaming system in patients with cardiovascular diseases at phase III cardiac rehabilitation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

changes of physical function between baseline and after 10-week exercise training

Key secondary outcomes

changes of Laboratory data between baseline and after 10-week exercise training


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

10-week exercise training using activity-promoting gaming systems

Interventions/Control_2


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

20 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

patients at phase III cardiac rehabilitation

Key exclusion criteria

patients with exercise-induced arrhythmia, ischemia, or blood pressure abnormality during cardiopulmonary exercise test and patients who are not applicable for home-exercise training.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Neiko
Middle name
Last name Ozasa

Organization

Kyoto University Hospital

Division name

Department of Cardiovascular medicine

Zip code

606-8507

Address

54

TEL

817575154255

Email

nei126@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Neiko
Middle name
Last name Ozasa

Organization

Kyoto University Hospital

Division name

Department of Cardiovascular medicine

Zip code

606-8507

Address

54

TEL

817575154255

Homepage URL


Email

nei126@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Kyoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

Information-technology Promotion Agency, Japan

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.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



Other administrative information

Date of disclosure of the study information

2016 Year 11 Month 05 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

2016 Year 11 Month 04 Day

Date of IRB

2016 Year 11 Month 14 Day

Anticipated trial start date

2016 Year 11 Month 07 Day

Last follow-up date

2017 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

2016 Year 11 Month 05 Day

Last modified on

2022 Year 11 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027651


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name