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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Patients are given a tailored daily activity goal in terms of steps per day for which to aim.
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.
A Fitbit will be worn by all participants to record daily activity.
Massachusetts General Hospital
Boston, Massachusetts, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Atlantic Health - Morristown Medical Center
Morristown, New Jersey, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Utah
Salt Lake City, Utah, United States
Average Daily Steps
Average daily steps over the intervention period
Time frame: Randomization to 6 weeks
Short Physical Performance Battery score
Combination of gait speed, balance test, and chair-to-stand test at the end of the intervention
Time frame: 6 week value, adjusted for baseline value
Quality of Life as measured with the KCCQ Overall Summary Score
KCCQ overall summary score
Time frame: 6 week value, adjusted for baseline value
5 meter gait time at the end of the intervention period
5 meter gait time at the end of the intervention period, adjusted for baseline
Time frame: Randomization to 6 weeks
Chair Sit to Stand Test
Time to complete 5 chair stands
Time frame: 6 week value, adjusted for baseline value
Balance Test Score at the end of the intervention period
Balance Test Score at the end of the intervention period, adjusted for baseline
Time frame: Randomization to 6 weeks
6 minute walk
6 minute walk distance at the end of the intervention period
Time frame: 6 week value, adjusted for baseline value
Handgrip
Handgrip strength
Time frame: 6 week value, adjusted for baseline value
Average number of hours per day with 250 or more steps
Average number of hours per day with 250 or more steps over the intervention period
Time frame: Randomization to 6 weeks
Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form
Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period
Time frame: Randomization to 6 weeks
Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form
Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period
Time frame: Randomization to 6 weeks
Physical Function as assessed by the NIH PROMIS computerized adaptive test
Physical Function as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Time frame: Randomization to 6 weeks
Depression as assessed by the NIH PROMIS computerized adaptive test
Depression as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Time frame: Randomization to 6 weeks
Fatigue as assessed by the NIH PROMIS computerized adaptive test
Fatigue as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Time frame: Randomization to 6 weeks
Dyspnea as assessed by the NIH PROMIS computerized adaptive test
Dyspnea as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Time frame: Randomization to 6 weeks
Daily Active Minutes (total)
Average daily active minutes (total)
Time frame: Randomization to 6 weeks
Daily Active Minutes of Moderate to High Intensity
Average daily minutes of moderate to high intensity
Time frame: Randomization to 6 weeks
Sedentary Minutes
Average daily sedentary minutes
Time frame: Randomization to 6 weeks
Daily Steps
Average daily steps
Time frame: 6 weeks post baseline to end of study
Daily Active Minutes (total)
Average daily active minutes (total)
Time frame: 6 weeks post baseline to end of study
Daily Active Minutes of Moderate to High Intensity
Average daily active minutes of moderate to high intensity
Time frame: 6 weeks post baseline to end of study
Daily Sedentary Minutes
Average daily sedentary minutes
Time frame: 6 weeks post baseline to end of study
KCCQ Overall Summary Score
KCCQ overall summary score, adjusted for baseline
Time frame: 6 weeks post baseline to end of study
Global Physical Health
Global physical health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline
Time frame: 6 weeks post baseline to end of study
Global Mental Health
Global mental health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline
Time frame: 6 weeks post baseline to end of study
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