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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024723
Receipt No. 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 2016/11/05

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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
Middle name
Last name Neiko Ozasa
Organization Kyoto University Hospital
Division name Department of Cardiovascular medicine
Zip code
Address 54 Kawahara-cho Sakyo-ku Kyoto
TEL 817575154255
Email nei126@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Neiko Ozasa
Organization Kyoto University Hospital
Division name Department of Cardiovascular medicine
Zip code
Address 54 Kawahara-cho Sakyo-ku Kyoto
TEL 817575154255
Homepage URL
Email nei126@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Kyoto University Hospital
Institute
Department

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
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
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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 07 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
2016 Year 11 Month 05 Day
Last modified on
2016 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.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


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