Abstract
BACKGROUND: Physical inactivity is highly prevalent in heart failure (HF) and chronic obstructive pulmonary disease (COPD) and is associated with poor outcomes, including worsened quality of life, increased hospitalizations, readmissions, and mortality. Accessible interventions that improve physical activity are needed. Mind-body strategies are well-suited for promoting physical activity; they show promise for targeting key health behavior change processes.
OBJECTIVE: The aim of this study was to examine the feasibility and acceptability of a web-based pedometer-mediated mind-body intervention (Mindful Steps) for promoting walking among individuals with HF and COPD.
METHODS: In this pilot randomized controlled trial, participants with chronic, stable HF and COPD were randomized to Mindful Steps or usual care in a 2:1 ratio. Mindful Steps is a 12-month multimodal intervention that includes a pedometer with individualized step-count goals, live mind-body exercise (MBE) classes, and a web platform with mind-body videos, motivation messages, and educational tips. Feasibility (recruitment rate, retention), intervention acceptability, and intervention adherence were the primary outcomes. Exploratory outcomes assessed at baseline, 3-, 6-, 9-, and 12-months included daily step counts, cognitive-behavioral/psychosocial measures, health-related quality of life, and self-reported physical function. Participants were enrolled in the study from April 2019 to July 2021. The study was converted to all-digital during the pandemic after March 2020.
RESULTS: Forty-one participants were randomized to Mindful Steps (n=26) or usual care (n=15). The recruitment rate was 3% (43/178), and overall study retention was 76% (31/41). In the intervention group, over 12 months, 58% (15/26) met a predefined benchmark for MBE class adherence (attending >70% of classes). Participants engaged most consistently with the MBE classes, the pedometer, and mind-body videos. There was a positive signal regarding group differences in the change in daily step counts from baseline, favoring intervention at 3 months (estimate=2038.77 steps per day between groups, 95% CI 289.76-3788.77), 6 months (estimate=3031.45, 95% CI 1261.15-4801.74), and 9 months (estimate=2703.80, 95% CI 862.97-4544.62). There were also positive signals regarding group differences in the change from baseline favoring intervention in the following outcomes: emotional awareness (estimate=0.88, 95% CI 0.15-1.61) and body listening (estimate=1.16, 95% CI 0.25-2.07) at 3-months; internal motivation (estimate=1.03, 95% CI 0.01-2.04) and pressure/tension at 6-months (estimate=-1.59, 95% CI -2.55 to -0.63); and exercise self-efficacy at 12 months (estimate=1.77, 95% CI 0.20-3.33).
CONCLUSIONS: Mindful Steps was largely feasible, acceptable, and had adequate intervention engagement. There were positive signals favoring the multimodal web intervention for daily step counts, interoceptive awareness, internal motivation, and exercise self-efficacy that will inform hypotheses in future studies. A pivot to fully remote conduct during the pandemic was successful. A larger trial examining the efficacy of Mindful Steps for promoting physical activity is warranted.
TRIAL REGISTRATION: ClinicalTrials.gov NCT03003780; https://clinicaltrials.gov/study/NCT03003780.