Exercise-therapy and education for individuals one year after anterior cruciate ligament reconstruction: a pilot randomised controlled trial

Abstract

Background: Guided rehabilitation beyond 6-months is rare following anterior cruciate ligament reconstruction (ACLR), despite high prevalence of unacceptable symptoms and quality of life (QoL). We aimed to: i) determine the feasibility of a randomised controlled trial (RCT) evaluating the effectiveness of a physiotherapist-guided lower-limb focussed exercise-therapy intervention for individuals 1-year post-ACLR with persistent symptoms, and ii) estimate the effects of this intervention compared to a trunk-focussed intervention on knee-related QoL.Design: Participant- and assessor-blinded, pilot feasibility RCT.Methods: Participant eligibility criteria: i) 12–15 months post-ACLR; ii) < 87.5/100 on the Knee injury and Osteoarthritis Outcome Score (KOOS) QoL subscale; and one of: a) one-leg rise test < 22 repetitions; b) single-hop < 90% limb symmetry; or c) Anterior Knee Pain Scale < 87/100. Participants were randomised (2:1 ratio) to lower-limb focussed exercise-therapy and individualised education, or trunk-focussed exercise-therapy and standardised education. Both interventions involved eight face-to-face physiotherapy sessions over 16-weeks, to guide allocated exercise-therapy programs. Feasibility was assessed by: i) recruitment (participants/month), ii) retention (< 20% drop-out), iii) physiotherapy attendance, and iv) unsupervised exercise-therapy program adherence (> 80% of 3 sessions/week). Knee-related QoL was evaluated using the KOOS-QoL subscale and ACL-QoL questionnaire, with between-group differences compared to published minimally important difference (MID) scores (KOOS-QoL = 10 points; ACL-QoL = 12 points).Results: 27 participants (3 participants/month; 48% men, 34 ± 12 years) were randomised. Two did not commence treatment, and two were lost to follow-up (16% drop-out). Physiotherapy attendance was > 80% for both groups but reported adherence to the unsupervised program was low (< 55% of prescribed exercises). KOOS-QoL improvement (mean ± SD) in the lower-limb focussed (23 ± 15) and trunk-focussed (16 ± 12) groups resulted in a between-group difference (mean, 95%CI) lower than the MID (7.1, -12.3 to 26.4). ACL-QoL improvement in the lower-limb focussed (20 ± 17) and trunk-focussed (22 ± 13) groups resulted in a between-group difference lower than the MID (-2.5, -18.2 to 13.2).Conclusions: A larger-scale RCT evaluating the effectiveness of a physiotherapist-guided lower-limb focussed program for individuals 1-year after ACLR with persistent symptoms is feasible. This intervention is associated with large within-group knee-related QoL improvements, but may not be superior to a trunk-focussed intervention.Trial Registration: Prospectively registered (ACTRN12616000564459).

SUpervised exercise-therapy and Patient Education Rehabilitation (SUPER) versus minimal intervention for young adults at risk of knee osteoarthritis after ACL reconstruction: SUPER-Knee randomised controlled trial protocol

“…Patient education was co-designed with experienced physiotherapists and pilot study participants23 and aims to support the exercise-therapy programme and build motivation and capability to sustain the exercises during and after the initial 4-month supervised phase (table 2). Individualised health education regarding expectations and goals, exercise principles, improving adherence, pain/fear management, long-term outcomes, weight control, and appropriate physical, occupational and sporting activity promotion will be delivered during the physiotherapy treatment sessions.…”

“…Where possible, data will be collected and managed using a secure web-based software platform (REDCap) hosted at La Trobe University,35 which has equivalent measurement properties to paper-based completion 36. This strategy was used in our pilot study following ACLR, with demonstrated feasibility 23. Paper versions will also be available if preferred by participants.…”

“…These young adults with inadequate recovery urgently need treatment options to alter their OA trajectory. Our feasibility study indicated that a full-scale randomised controlled trial (RCT) evaluating a physiotherapist-led, exercise-therapy and education programme for young adults with ongoing symptoms approximately 1 year after ACLR (ie, when no further improvement is likely without treatment) is feasible and likely associated with a clinically worthwhile effect for pain, function and quality of life 23…”

Effectiveness of rehabilitation interventions to optimise symptomatic, functional, psychological and quality of life outcomes, and prevent reinjury after knee injury: A systematic review of systematic reviews

“…[54,55] Clinical trials evaluating the effect of rehabilitation interventions beyond the first postoperative year, particularly for those with or at high risk of (early) post-traumatic OA are required. [56] The fact that most evidence was based on findings in males (56-95% male participants in each systematic review), highlights the importance of considering how females respond to ACL rehabilitation interventions. This is pertinent given that females have a higher risk of primary ACL injury [57] and generally have poorer outcomes following ACL injury than their male counterparts.…”

An anti-inflammatory diet intervention for knee osteoarthritis: a feasibility study

“…We initially aimed to enrol 60 participants (n = 30 antiinflammatory diet, n = 30 control) based on previous feasibility trials evaluating health-professional guided interventions for musculoskeletal conditions [30][31][32] which was deemed sufficient to assess feasibility parameters. Due to COVID-19, our study was adapted to a single-arm feasibility study, in which we aimed to enrol 30 participants into the anti-inflammatory diet intervention.…”