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

2020 ◽  
Author(s):  
Brooke Patterson ◽  
Christian Barton ◽  
Adam Culvenor ◽  
Randall Cooper ◽  
Kay Crossley

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).

2021 ◽  
Author(s):  
Brooke Patterson ◽  
Christian Barton ◽  
Adam Culvenor ◽  
Randall Cooper ◽  
Kay Crossley

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).


2020 ◽  
Author(s):  
Brooke Patterson ◽  
Christian Barton ◽  
Adam Culvenor ◽  
Randall Cooper ◽  
Kay Crossley

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).


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