A multicenter EXploratory randomizEd controlled tRial to validate a physiCal traIning Support and Education program in patients with Heart Failure
- Conditions
- Heart FailureD006333
- Registration Number
- JPRN-jRCT2032230388
- Lead Sponsor
- Katsumata Yoshinori
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
(1) Those who are 18 years of age or older
(2) Those who have had structural or functional abnormalities in the myocardium during the period from 1 year before consent to the start of actual use of the exercise support app
(3) Those whose clinical test values of NT-proBNP and BNP exceed the specified values during the period from one year before consent to the start of actual use of the exercise support app.
(4) Persons who fully understand and can provide written consent
(5) Those who have a smartphone (Android (11 or later) or iOS (16 or later)) and email address ready, and who agree to download the necessary programs to their smartphone.
(1) Those with contraindications to exercise therapy or exercise stress tests
(2) Those who have regularly performed moderate to intense exercise (three or more times a week) within the last 6 weeks after giving consent
(3) Patients who use an exercise support application with a smart-device
(4) New York Heart Association (NYHA) Cardiac Function Classification Class III or IV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in peak VO2 12 weeks after the start of interventional therapy
- Secondary Outcome Measures
Name Time Method Changes in peak VO2 24 weeks after the start of interventional therapy<br>Changes in KCCQ overall summary scores and scores for each domain<br>Changes in NT-proBNP<br>Amount of physical activity<br>All-cause mortality rate<br>- Incidence of cardiovascular death<br>- Incidence of readmission due to heart failure<br>- Incidence of unscheduled outpatient visits for exacerbation of heart failure