severe aortic valve stenosis
Conditions
Interventions
Patients indicated for TAVI will be fitted with a wearable device (Fitbit) at the start of their first post-TAVI exercise rehearsal. The primary outcome will be the 3-month retention rate of wearing
Sponsors
Shonan Kamakura General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are eligible 1) Patients who have undergone TAVI in severe aortic stenosis 2) Patients aged 60 years or older at the time of consent (regardless of gender) 3) Research subjects who have given a full explanation of their participation in this study and have given their free written consent. 4) Patients scheduled for outpatient cardiac rehabilitation
Exclusion criteria
Exclusion criteria: Patients who violate any of the following conditions will not be included in this study 1) Patients who do not have a reliable Internet connection at home, do not have a smartphone, or are otherwise unable to establish a Fitbit use environment. 2) Patients for whom exercise therapy is contraindicated 3) Patients who have difficulty performing the exercise tolerance test due to other diseases or pain 4) Patients who have difficulty operating the Fitbit due to visual or hearing impairment 5) Patients who have experienced hypotension, fatal arrhythmia, or other adverse events during cardiac rehabilitation, exercise stress tests, or exercise therapy. 5) Patients who have experienced hypotension, fatal arrhythmia or other adverse events during cardiac rehabilitation, exercise testing or exercise therapy 6) Patients scheduled to undergo inpatient cardiac rehabilitation for more than 4 weeks 7) Patients who have participated in other clinical trials or clinical studies involving interventions within the past 12 weeks of obtaining consent 8) Patients who the investigator determines to be incapable of correctly understanding the significance of the research and complying with the compliance requirements due to dementia, mental illness, etc. 9) Other patients who are judged by the principal investigator to be inappropriate as research subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Fitbit wearers who continue to wear the Fitbit at 3 months after TAVI | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The following items at the beginning of the intervention and 3 months later 6-minute walking distance over time 2) Representative values (mean, median, mode, maximum, and minimum) of number of steps and heart rate measured by Fitbit | — |
Countries
Japan
Contacts
Public ContactFutoshi Yamanaka
Shonan Kamakura General Hospital Cardiac Center
Outcome results
None listed