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).

Figure 1

Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
Physiotherapist manual: exercise-therapy and education protocols.pdf
Feedback from study participants on exercise program content, structure and delivery methods.pdf
Secondary objective outcomes additional detail.pdf
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Received 29 Nov, 2020
On 24 Nov, 2020
Invitations sent on 24 Nov, 2020
On 24 Nov, 2020
On 15 Nov, 2020
On 15 Nov, 2020
On 15 Nov, 2020
Posted 11 Aug, 2020
On 11 Sep, 2020
Received 10 Sep, 2020
Received 30 Aug, 2020
On 13 Aug, 2020
Received 13 Aug, 2020
On 11 Aug, 2020
Invitations sent on 10 Aug, 2020
On 10 Aug, 2020
On 10 Jul, 2020
On 09 Jul, 2020
On 09 Jul, 2020
On 08 Jul, 2020
On 24 Dec, 2020
On 22 Dec, 2020
On 22 Dec, 2020
On 22 Dec, 2020
Received 15 Dec, 2020
Received 29 Nov, 2020
On 24 Nov, 2020
Invitations sent on 24 Nov, 2020
On 24 Nov, 2020
On 15 Nov, 2020
On 15 Nov, 2020
On 15 Nov, 2020
Posted 11 Aug, 2020
On 11 Sep, 2020
Received 10 Sep, 2020
Received 30 Aug, 2020
On 13 Aug, 2020
Received 13 Aug, 2020
On 11 Aug, 2020
Invitations sent on 10 Aug, 2020
On 10 Aug, 2020
On 10 Jul, 2020
On 09 Jul, 2020
On 09 Jul, 2020
On 08 Jul, 2020
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).

Figure 1

Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
Physiotherapist manual: exercise-therapy and education protocols.pdf
Feedback from study participants on exercise program content, structure and delivery methods.pdf
Secondary objective outcomes additional detail.pdf
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