Feasibility Randomized Controlled Trial of a Mind-Body Activity Program for Older Adults With Chronic Pain and Cognitive Decline: The Virtual "Active Brains" Study.

Abstract

Chronic pain (CP) and cognitive decline (CD) are highly comorbid and debilitating among older adults. We iteratively developed Active Brains-Fitbit (AB-F), a group mind-body activity program aided by a Fitbit that is feasible and associated with improvements in physical, cognitive, and emotional functioning when delivered in-person to older adults with CP and CD. We adapted our intervention and methodology for remote delivery to bypass barriers to participation. Here we report on a feasibility randomized controlled trial of the virtual AB-F versus a Health Enhancement Program (HEP) educational control followed by qualitative exit interviews. Older adults (aged ≥60) with CP and CD (2 cohorts) completed 8 weeks of AB-F (n = 8) or HEP (n = 11). Study procedures were fully remote via live video. Quantitative analyses explored feasibility and acceptability markers and within-group improvements in outcomes. Qualitative analyses were primarily deductive using the Framework Method. AB-F met a priori set feasibility benchmarks, similar to our in-person pilot. Participation in AB-F was associated with preliminary signals of improvement in multimodal physical function, emotional function (anxiety), cognitive function, pain intensity, and coping (e.g., pain self-efficacy, catastrophizing). Participation in HEP was associated with smaller or negligible improvements. Exit interviews confirmed feasibility and satisfaction with our completely remote interventions and methodology. Results provide evidence for the feasibility of our completely remote study and for initial markers of improvement after AB-F. The results will inform a fully powered remote efficacy trial. NCT04044183.