UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009043 |
|---|---|
| Receipt number | R000010616 |
| Scientific Title | Usefulness of automatic home blood pressure monitoring and physical activity monitoring for home exercise training and patient education in cardiac rehabilitation |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2023/04/19 14:03:11 |
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Basic information
Public title
Usefulness of automatic home blood pressure monitoring and physical activity monitoring for home exercise training and patient education in cardiac rehabilitation
Acronym
Usefulness of automatic home blood pressure monitoring and physical activity monitoring in cardiac rehabilitation
Scientific Title
Usefulness of automatic home blood pressure monitoring and physical activity monitoring for home exercise training and patient education in cardiac rehabilitation
Scientific Title:Acronym
Usefulness of automatic home blood pressure monitoring and physical activity monitoring in cardiac rehabilitation
Region
| Japan |
Condition
Condition
Patients who have undergone first percutaneous coronary intervention
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between home blood pressure, physical activity and changes of exercise capacity in patients who participated cardiac rehabilitation after percutaneous coronary intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The association between home blood pressure/physical activity and changes of exercise capacity during 3 months.
Key secondary outcomes
The association between home blood pressure/physical activity and changes of biomarker during 3 months.
The association between home blood pressure/physical activity and changes of exercise capacity and biomarker during 5 months.
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
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Automatic home blood pressure monitoring and physical activity monitoring for home exercise training and patient education in cardiac rehabilitation.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Consecutive patients who have undergone first percutaneous coronary intervention and participated in cardiac rehabilitation program at Kyoto University Hospital.
Key exclusion criteria
Patients with contraindications for endurance exercise training, patients undergoing dialysis, patients with dementia.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Neiko |
| Middle name | |
| Last name | Ozasa |
Organization
Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
606-8153
Address
54 Kawahara-cho, Syogoin, Sakyo-ku, Kyoto, Kyoto, Japan
TEL
075-751-4255
nei126@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Neiko |
| Middle name | |
| Last name | Ozasa |
Organization
Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
606-8153
Address
54 Kawahara-cho, Syogoin, Sakyo-ku, Kyoto, Kyoto, Japan
TEL
075-751-4099
Homepage URL
nei126@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
OMRON Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
| 2012 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
UMIN000009043
Publication of results
Published
Result
URL related to results and publications
https://kmuhsc.net/clext/index.html
Number of participants that the trial has enrolled
15
Results
Fifteen patients with CAD who underwent first PCI were included in this study(OMI/AP 11/4, 9male, median age 70/range 42-79). After 3 months, 12 patients who conducted more than 150 min moderate-intensity exercise per week shows significant improvement in Peak VO2 and AT(paired t-test,p<0.01). Good home blood pressure control (SBP<125mmHg) was associated with increased Peak VO2 and increased AT(paired t-test p<0.05).
Results date posted
| 2023 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with CAD who underwent first PCI
Participant flow
Among 33 patients with CAD who underwent first PCI was in　Kyoto University Hospital, 17　patients were included in this study. Study patients were monitored home blood pressure and physical activity using Medical LINK(OMRON Healthcare CO.Ltd) and participated in out patient cardiac rehabilitation program for 3 months.Patients underwent CPX examination at baseline and after 3months. Two patients withdraw from the study. Accordingly, 15 patients were included in the final analysis.
Adverse events
UAP, 1case
fracture, 1case
No association with intervention was observed.
Outcome measures
Peak VO2 and AT measured by CPX
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 09 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 24 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 24 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010616
