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

Gerontologist. 2022 Aug 12;62(7):1082-1094. doi: 10.1093/geront/gnab135.

Abstract

Background and objectives: 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.

Research design and methods: 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.

Results: 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.

Discussion and implications: 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.

Clinical trial registration: NCT04044183.

Keywords: Chronic illness; Chronic pain; Cognitive decline; Mind–body; Physical activity.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Brain
  • Chronic Pain* / therapy
  • Cognitive Dysfunction* / therapy
  • Feasibility Studies
  • Humans
  • Pain Measurement

Associated data

  • ClinicalTrials.gov/NCT04044183