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). Our primary aim was to determine the feasibility of a randomised controlled trial (RCT) evaluating a physiotherapist-guided intervention for individuals 1-year post-ACLR with persistent symptoms. Our secondary aim was to determine if a worthwhile treatment effect could be observed for the lower-limb focussed intervention (compared to the trunk-focussed intervention), for improvement in knee-related QoL, symptoms, and function. 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 either a one-leg rise test < 22 repetitions, single-hop < 90% limb symmetry; or Anterior Knee Pain Scale < 87/100. Participants were randomised to lower-limb or trunk-focussed focussed exercise and education. Both interventions involved 8 face-to-face physiotherapy sessions over 16-weeks. Feasibility was assessed by eligibility rate (> 1 in 3 screened), recruitment rate (> 4 participants/month), retention (< 20% drop-out), physiotherapy attendance and unsupervised exercise adherence (> 80%). Between-group differences for knee-related QoL (KOOS-QoL, ACL-QoL), symptoms (KOOS-Pain, KOOS-Symptoms), and function (KOOS-Sport, functional performance tests) were used to verify that the worthwhile effect (greater than the minimal detectable change for each measure) was contained within the 95% confidence interval. Results 47% of those screened were eligible, and 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 unsupervised exercise was low (< 55%). Both interventions had potentially worthwhile effects for KOOS-QoL and ACL-QoL, while the lower-limb focussed intervention had potentially greater effects for KOOS-Sport, KOOS-Pain, and functional performance. Conclusions A larger-scale RCT is warranted. All feasibility criteria were met, or reasonable recommendations could be made to achieve the criteria in future trials. Strategies to increase recruitment rate and exercise adherence are required. The potential worthwhile effects for knee-related QoL, symptoms, and function indicates a fully-powered RCT may detect a clinically meaningful effect. Trial registration Prospectively registered (ACTRN12616000564459).

Feasibility of the SOAR (Stop OsteoARthritis) program

“…Based on findings ranging from 80% on the PT numerical rating of participant action-plan completion to 96% full or partial completion of exercise-therapy SMART goals there was consistent evidence of high participant adherence across the program. These results are more favorable than those reported for other exercise intervention in similar populations [ 48 ], and may be related to the use of action-planning, a behavioural change technique positively associated with exercise adherence [ 28 ], and meaningful therapeutic relationships between participants and their PT [ 39 ].…”

“…Descriptive statistics for all participant characteristics, outcomes and open-ended survey responses were summarized by gender given their socio-cultural nature. A priori benchmarks were set for key implementation and practicality outcomes based on past feasibility studies [ 47 , 48 ] and clinical experience. These included: participant attrition 10%; 80% knee-camp and weekly session attendance; 24 out of 30 Fitbit wear days (≥15-h of daily wear); median EARS score of 18 (75% adherence); 80% participant numerical rating of adherence, 80% PT numerical rating of participant adherence, 75% intervention fidelity; median CARE measure score of 38 (75% relationship empathy); 80% full or partial SMART goal completion.…”

Rehabilitation after anterior cruciate ligament and meniscal injuries: a best-evidence synthesis of systematic reviews for the OPTIKNEE consensus

“…Persistent symptoms and functional impairments are common, and may increase the risk of early post-traumatic OA following ACL injury 56 57. 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 58. The fact that most evidence was based on findings in men (56%–95% male participants in each systematic review) highlights the importance of considering how women respond to ACL rehabilitation interventions.…”

“… 56 57 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. 58 The fact that most evidence was based on findings in men (56%–95% male participants in each systematic review) highlights the importance of considering how women respond to ACL rehabilitation interventions. This is pertinent given that women have a higher risk of primary ACL injury 59 and generally have poorer outcomes following ACL injury than their male counterparts.…”

Trajectory of knee health in runners with and without heightened osteoarthritis risk: the TRAIL prospective cohort study protocol

“…Interviews with 27 ACLR participants from a previous trial 100 informed the design and development of the research questions of our prospective cohort study. Their knowledge and beliefs about running and OA risk after knee surgery (‘I want to be able to go for a run – but my surgeon told me running was bad for my knees’; 17/27 agree/strongly agree that repetitive joint loading increased the risk of OA) highlighted the need to better understand the relationship between running exposure with knee joint health and symptoms.…”