Effect of a pragmatic home-based mobile health exercise intervention after transcatheter aortic valve replacement: a randomized pilot trial

Brian R Lindman, Linda D Gillam, Megan Coylewright, Frederick G P Welt, Sammy Elmariah, Stephanie A Smith, David A McKeel, Natalie Jackson, Kush Mukerjee, Harrison Cloud, Narden Hanna, Jenelle Purpura, Hannah Ellis, Vong Martinez, Alexandra M Selberg, Shi Huang, Frank E Harrell Jr, Brian R Lindman, Linda D Gillam, Megan Coylewright, Frederick G P Welt, Sammy Elmariah, Stephanie A Smith, David A McKeel, Natalie Jackson, Kush Mukerjee, Harrison Cloud, Narden Hanna, Jenelle Purpura, Hannah Ellis, Vong Martinez, Alexandra M Selberg, Shi Huang, Frank E Harrell Jr

Abstract

Aims: Impaired physical function is common in patients undergoing transcatheter aortic valve replacement (TAVR) and associated with worse outcomes. Participation in centre-based cardiac rehabilitation (CR) after cardiovascular procedures is sub-optimal. We aimed to test a home-based mobile health exercise intervention as an alternative or complementary approach.

Methods and results: At five centres, after a run-in period, eligible individuals treated with TAVR were randomized 1:1 at their 1-month post-TAVR visit to an intervention group [activity monitor (AM) with personalized daily step goal and resistance exercises] or a control group for 6 weeks. Among 50 participants, average age was 76 years, 34% were female, average STS score was 2.91.8, and 40% had Short Physical Performance Battery (SPPB) 9. Daily compliance with wearing the AM and performing exercises averaged 8590%. In the intention to treat population, there was no evidence that the intervention improved the co-primary endpoints: daily steps +769 (95% CI 244 to +1783); SPPB +0.68 (0.27 to 1.53); and Kansas City Cardiomyopathy Questionnaire 1.7 (9.1 to 7.1). The intervention did improve secondary physical activity parameters, including moderate-to-intense daily active minutes (P<0.05). In a pre-specified analysis including participants who did not participate in CR (n=30), the intervention improved several measures of physical activity: +1730 (1003360) daily steps; +66 (28105) daily active minutes; +53 (2780) moderate-to-intense active minutes; and 157 (265 to 50) sedentary minutes.

Conclusion: Among selected participants treated with TAVR, this study did not provide evidence that a pragmatic home-based mobile health exercise intervention improved daily steps, physical performance or QoL for the overall cohort. However, the intervention did improve several measures of daily activity, particularly among individuals not participating in CR.

Trial registry: Clinicaltrials.gov NCT03270124.

Keywords: Accelerometer; Actigraphy; Aortic stenosis; Cardiac rehabilitation; Frailty; Mobile health; Transcatheter aortic valve replacement.

The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Graphical abstract
Graphical abstract
Figure 1
Figure 1
Activity monitor and exercise compliance during the intervention period. Compliance is reported by day throughout the study period for wearing the activity monitor among the whole population (A) and by assigned group (B); and for performance of daily exercises among the intervention group (C).
Figure 2
Figure 2
Daily steps. The left panels represent the model estimated daily steps by assigned group over the 6-week study period (green represents the intervention group; orange represents the control group) for the intention to treat population (n = 50) (A), compliant population (n = 46) (C), and participants who did not participate in cardiac rehabilitation during the study period (n = 30) (E). The shaded area represents the 95% confidence interval. Models were adjusted for age, sex, baseline gait speed, baseline steps, and, except for E, participation in cardiac rehabilitation. The right panels represent the difference in daily steps (intervention group – control group) for the intention to treat population (B), compliant population (D), and participants who did not participate in cardiac rehabilitation during the study period (F). The shaded area represents the 95% confidence interval adjusting for multiple comparisons. The blue line represents the individual 95% confidence interval that is not adjusted for multiplicity at Day 42.
Figure 3
Figure 3
Daily active minutes. The left and right panels show data exactly as described in Figure 2 except that daily active minutes are displayed in this figure.
Figure 4
Figure 4
Daily active minutes of moderate to high intensity. The left and right panels show data exactly as described in Figure 2 except that daily active minutes of moderate to high intensity are displayed in this figure.
Figure 5
Figure 5
Daily sedentary minutes. The left and right panels show data exactly as described in Figure 2 except that daily sedentary minutes are displayed in this figure.
Figure 6
Figure 6
Daily number of hours with ≥250 steps. The left and right panels show data exactly as described in Figure 2 except that daily hours with ≥250 steps are displayed in this figure.

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Source: PubMed

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