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
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
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
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
