ACTIVE AFTER TAVR 2017.

Study name	A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement (ACTIVE AFTER TAVR): a pilot study
Methods	Parallel‐assignment RCT
Participants	Subjects who have been treated commercially with TAVR with a SAPIEN 3 valve and are being discharged to home
Interventions	Active comparator: no resistance exercise and no activity goal arm; blinded use of Fitbit with no daily activity goal and no resistance exercises Experimental: resistance exercise and activity goal arm; unblinded use of Fitbit with daily activity goal (steps per day) and resistance exercises
Outcomes	Primary outcome measures Average daily steps [Time Frame: randomization to 6 weeks, average daily steps over the intervention period] Short physical performance battery score [Time Frame: 6‐week value, adjusted for baseline value, combination of gait speed, balance test, and chair‐to‐stand test at end of intervention] Quality of life as measured with KCCQ Overall Summary Score [Time Frame: 6‐week value, adjusted for baseline value, KCCQ overall summary score] Secondary outcome measures 5‐meter gait time at end of intervention period [Time Frame: randomisation to 6 weeks, 5‐meter gait time at end of intervention period, adjusted for baseline] Chair sit‐to‐stand test [Time Frame: 6‐week value, adjusted for baseline value, time to complete 5 chair stands] Balance test score at end of intervention period [Time Frame: randomisation to 6 weeks, balance test score at end of intervention period, adjusted for baseline] 6‐minute walk [Time Frame: 6‐week value, adjusted for baseline value, 6‐minute walk distance at end of intervention period] Handgrip [Time Frame: 6‐week value, adjusted for baseline value, handgrip strength' Average number of hours per day with 250 or more steps [Time Frame: randomisation to 6 weeks, average number of hours per day with 250 or more steps over intervention period] Average global physical health as assessed by PROMIS Global Health 10 Short Form [Time Frame: randomisation to 6 weeks, average global physical health as assessed by PROMIS Global Health 10 Short Form over intervention period] Average global mental health as assessed by PROMIS Global Health 10 Short Form [Time Frame: randomisation to 6 weeks, average global mental health as assessed by PROMIS Global Health 10 Short Form over intervention period] Physical function as assessed by NIH PROMIS computerised adaptive test [Time Frame: randomisation to 6 weeks, physical function as assessed by NIH PROMIS computerised adaptive test, adjusted for baseline] Depression as assessed by NIH PROMIS computerised adaptive test [Time Frame: randomisation to 6 weeks, depression as assessed by NIH PROMIS computerised adaptive test, adjusted for baseline] Fatigue as assessed by NIH PROMIS computerised adaptive test [Time Frame: randomisation to 6 weeks, fatigue as assessed by NIH PROMIS computerised adaptive test, adjusted for baseline] Dyspnoea as assessed by NIH PROMIS computerised adaptive test [Time Frame: randomisation to 6 weeks, dyspnoea as assessed by NIH PROMIS computerised adaptive test, adjusted for baseline] Daily active minutes (total) [Time Frame: randomisation to 6 weeks, average daily active minutes (total) Daily active minutes of moderate to high intensity [Time Frame: randomisation to 6 weeks, average daily minutes of moderate to high intensity] Sedentary minutes [Time Frame: randomisation to 6 weeks, average daily sedentary minutes] Daily steps [Time Frame: 6 weeks post baseline to end of study, average daily steps] Daily active minutes (total) [Time Frame: 6 weeks post baseline to end of study, average daily active minutes (total)] Daily active minutes of moderate to high intensity [Time Frame: 6 weeks post baseline to end of study, average daily active minutes of moderate to high intensity] Daily sedentary minutes [Time Frame: 6 weeks post baseline to end of study, average daily sedentary minutes] KCCQ Overall Summary Score [Time Frame: 6 weeks post baseline to end of study, KCCQ overall summary score, adjusted for baseline] Global physical health [Time Frame: 6 weeks post baseline to end of study, global physical health as assessed by PROMIS Global Health 10 Short Form, adjusted for baseline] Global mental health [Time Frame: 6 weeks post baseline to end of study, global mental health as assessed by PROMIS Global Health 10 Short Form, adjusted for baseline]
Starting date	7 November 2017
Contact information	Brian Lindman, Associate Professor, Vanderbilt University Medical Center
Notes	Estimated enrolment: 85 participants. Estimated study completion date: August 2020 Location: Massachusetts General Hospital, Dartmouth‐Hitchcock Medical Center, Atlantic Health ‐ Morristown Medical Center, Vanderbilt University Medical Center, University of Utah