Self-directed versus supervised exercise therapy program combined with digitally supported patient education for knee osteoarthritis: a randomised, parallel-group feasibility trial

Abstract

Introduction: Research comparing self-directed and supervised exercise therapy for knee osteoarthritis (KOA) is limited. This study evaluates the feasibility of a randomised controlled trial (RCT) comparing self-directed and supervised exercise therapy combined with education for people with KOA.

Materials and methods: Participants with a clinical diagnosis of KOA, living in Greater Melbourne, were recruited via advertisements on community notice boards and on social media. Each attended two online education sessions and accessed the web-based 'My Knee' education and self-management toolkit to support their learning and exercise completion. Participants were then randomised to self-directed or supervised exercise therapy and encouraged to complete ≥12 exercise therapy sessions (2x week) over at least six weeks. Feasibility outcomes included recruitment, retention, data completion (monitored by checking the completion status of the questionnaires), education and exercise therapy sessions completion. Between group differences for Knee Injury and Osteoarthritis Outcome Score-12 (KOOS-12) and European Quality of Life 5 Dimensions 5-Level Version (EQ-5D-5L) estimated whether treatment effects were clinically meaningful (i.e. minimal detectable change contained within the 95 % confidence interval).

Results: Over 6-months, 67 people expressed interest, 26 were eligible, and 24 consented to participate. All participants attended both education sessions, and none dropped out. Eighty-eight percent (15/17) of self-directed and 57 % (4/7) of the supervised participants completed the logbook. Completed logbook data indicated ≥12 exercises sessions were completed by 93 % of self-directed and all supervised participants. All feasibility criteria were met, or can be addressed in future trials. Clinically meaningful treatment effects were contained within the 95 % CI for all KOOS-12 subscales and the EQ-5D-5L in the self-directed group.

Conclusion: A larger-scale non-inferiority RCT is feasible, with strategies to increase recruitment rate and data completion.

Trial registration: ANZCTR Registration (ACTRN12623000123640).

Keywords: Exercise; Knee pain; Osteoarthritis; Pilot trial; Rehabilitation.