Abstract
BACKGROUND: Anterior cruciate ligament (ACL) reconstruction, using hamstring auto-graft is a common surgical procedure, which often leads to persistent hamstring muscle-strength deficiency and reduced function. The purpose of this randomized controlled trial (RCT) is to investigate the effect of a combined, progressive, strength and neuromuscular exercise intervention on knee muscle strength, functional capacity and hamstring muscle-tendon morphology in ACL-reconstructed patients with persistent hamstring muscle-strength deficiency compared with controls. METHODS/DESIGN: The study is designed as a multicenter, parallel-group RCT with balanced randomization (1:1) and blinded outcome assessments (level of evidence: II) and will be reported in accordance with the CONSORT Statement. Fifty ACL-reconstructed patients (hamstring auto-graft) with persistent limb-to-limb knee-flexor muscle-strength asymmetry at 12-24 months' post surgery, will be recruited through outpatient clinics and advertisements. Patients will be randomized to a 12-week progressive, strength and neuromuscular exercise group (SNG) with supervised training twice weekly or a control intervention (CON) consisting of a home-based, low-intensity exercise program. Outcome measures include between-group change in maximal isometric knee-flexor strength (primary outcome) and knee-extensor muscle strength, hamstring-to-quadriceps strength ratios of the leg that has been operated on and Knee injury and Osteoarthritis Outcome Score (KOOS) (secondary outcomes). In addition, several explorative outcomes will be investigated: The International Knee Documentation Committee Subjective Knee Form (IKDC), the Tegner Activity Score, rate of force development (RFD) for the knee flexors and extensors, tendon regeneration and potential muscle hypertrophy at graft harvest site evaluated by magnetic resonance imaging (MRI), postural control, kinetic/kinematic gait characteristics and knee-related functional capacity. DISCUSSION: This RCT is designed to investigate the effect of combined, progressive-resistance and neuromuscular exercises on knee-flexor/extensor strength, in the late rehabilitation phase following ACL reconstruction. Reduced hamstring strength represents a potential risk factor for secondary ACL rupture and accelerated progression of osteoarthritis. If deemed effective, the intervention paradigm introduced in this study may help to improve current treatment strategies in ACL-reconstructed patients. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02939677 (recruiting). Registered on 20 October 2016.