Aortic Valve Stenosis
Conditions
Keywords
Aortic Valve Stenosis, Fitbit, iPAD, Physical Exercises, Quality of Life
Brief summary
This study is being performed in patients who have undergone transcatheter aortic valve replacement (TAVR) for aortic stenosis. The goal is to obtain pilot and feasibility data on a novel post-procedure rehabilitation strategy, including a daily activity goal using a fitness tracking device (Fitbit Alta HR) and in-home resistance training exercises targeting muscles related to activities of daily living. We will evaluate the effect of these interventions on physical performance and several quality of life domains.
Detailed description
The study will be conducted in three phases. Subjects who have been treated commercially with TAVR with a SAPIEN 3 valve and are being discharged to home will be eligible for Phase 1. Once consented prior to discharge, patients will complete the KCCQ, PROMIS Questionnaires, 5m walk, chair stand, and handgrip tests. During phase 1, all subjects will have a Fitbit and answer quality of life questions on the iPad about their activities and quality of life. After 30 days, the subject will return to complete the PROMIS Questionnaires, 5m walk, chair stand, balance tests, and handgrip tests, as well as a KCCQ. If the subject has consistently provided data throughout Phase 1, they will be asked to continue on to Phases 2 and 3 and complete a 6 minute walk test at this baseline visit. For Phase 2, subjects will be randomized to one of two arms. In one arm, they will have a daily activity goal and resistance exercises; in the other arm, there will not be a daily activity goal and no resistance exercises given. After 6 weeks, the subject will return to complete the 5m walk, 6 minute walk test, chair stand, balance tests, and handgrip tests, PROMIS Questionnaires, as well as a KCCQ. Five months after enrollment into Phase 2, subjects will be given a Fitbit to track their daily activity for 1 week (Phase 3). They will also complete a KCCQ, PROMIS Questionnaires, and end of study questionnaire.
Interventions
BEHAVIORALDaily Activity Goal
Patients are given a tailored daily activity goal in terms of steps per day for which to aim.
BEHAVIORALResistance Exercises
Patients will instructed to perform 3 different resistance exercises targeting muscles pertinent to activities of daily living on 6 out of 7 days a week.
BEHAVIORALDaily Activity Recording
A Fitbit will be worn by all participants to record daily activity.
Sponsors
Edwards Lifesciences
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase 1 - Starts after the TAVR procedure and prior to discharge • Patients treated commercially with TAVR with a SAPIEN 3 valve Phases 2 and 3 - Starts at 30 day post-TAVR follow-up visit • Patients enrolled in Phase 1
Exclusion criteria
Phase 1 - Starts after the TAVR procedure and prior to discharge * Stroke during or immediately after the TAVR procedure prior to discharge * Inability to walk * Non-English speaking (because the mobile app and CAT questionnaires are only in English) * Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments. These limitations may include, but are not limited to: blindness, neuropathy, severe tremor or disabling motor deficit, cognitive impairment (documentation of dementia in the medical record), or illiteracy. * Unwillingness or inability of the subject to provide informed consent for Phase 1 (no LARs allowed) * Planned discharge from hospital to skilled nursing or rehabilitation facility Phases 2 and 3 - Starts at 30 day post-TAVR follow-up visit * All
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Steps | Randomization to 6 weeks | Average daily steps over the intervention period |
| Short Physical Performance Battery score | 6 week value, adjusted for baseline value | Combination of gait speed, balance test, and chair-to-stand test at the end of the intervention |
| Quality of Life as measured with the KCCQ Overall Summary Score | 6 week value, adjusted for baseline value | KCCQ overall summary score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 minute walk | 6 week value, adjusted for baseline value | 6 minute walk distance at the end of the intervention period |
| Handgrip | 6 week value, adjusted for baseline value | Handgrip strength |
| Average number of hours per day with 250 or more steps | Randomization to 6 weeks | Average number of hours per day with 250 or more steps over the intervention period |
| Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form | Randomization to 6 weeks | Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period |
| Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form | Randomization to 6 weeks | Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period |
| Physical Function as assessed by the NIH PROMIS computerized adaptive test | Randomization to 6 weeks | Physical Function as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline |
| Depression as assessed by the NIH PROMIS computerized adaptive test | Randomization to 6 weeks | Depression as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline |
| Fatigue as assessed by the NIH PROMIS computerized adaptive test | Randomization to 6 weeks | Fatigue as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline |
| 5 meter gait time at the end of the intervention period | Randomization to 6 weeks | 5 meter gait time at the end of the intervention period, adjusted for baseline |
| Daily Active Minutes (total) | Randomization to 6 weeks | Average daily active minutes (total) |
| Daily Active Minutes of Moderate to High Intensity | Randomization to 6 weeks | Average daily minutes of moderate to high intensity |
| Sedentary Minutes | Randomization to 6 weeks | Average daily sedentary minutes |
| Daily Steps | 6 weeks post baseline to end of study | Average daily steps |
| Daily Sedentary Minutes | 6 weeks post baseline to end of study | Average daily sedentary minutes |
| KCCQ Overall Summary Score | 6 weeks post baseline to end of study | KCCQ overall summary score, adjusted for baseline |
| Global Physical Health | 6 weeks post baseline to end of study | Global physical health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline |
| Global Mental Health | 6 weeks post baseline to end of study | Global mental health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline |
| Dyspnea as assessed by the NIH PROMIS computerized adaptive test | Randomization to 6 weeks | Dyspnea as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline |
| Chair Sit to Stand Test | 6 week value, adjusted for baseline value | Time to complete 5 chair stands |
| Balance Test Score at the end of the intervention period | Randomization to 6 weeks | Balance Test Score at the end of the intervention period, adjusted for baseline |
Countries
United States
Outcome results
None listed