The Efficacy of Rehabilitation Exercise on the Non-operative Limb Following Anterior Cruciate Ligament Reconstruction
Condition: Musculoskeletal System
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of a cross-education rehabilitation
      intervention following anterior cruciate ligament reconstruction on ameliorating the acute
      losses to function and performance. The cross-education phenomenon describes the strength
      gain in the opposite, untrained (surgical) limb following unilateral resistance training of
      the 'trained' (non-surgical) limb.
    

Detailed description: 
      Protocol:

      44 eligible and consenting patients (allowing for 20% attrition) with unilateral anterior
      cruciate ligament (ACL) injury that have elected to undergo surgical reconstruction will be
      recruited into this study. Patients will be randomly assigned to one of two different
      conditions: 1) standard ACL rehabilitation plus 8-weeks of contralateral muscle resistance
      training, [INTERVENTION]; 2) standard ACL rehabilitation plus placebo exercises (time-matched
      unrelated upper limb flexibility exercises, [CONTROL].

      Assessments of knee extensor and knee flexor neuromuscular performance of both limbs will be
      obtained prior to, at 10-weeks post- and at 6-months post- surgery. Assessments of function
      (1-leg hop for distance) and patient-reported outcomes (International Knee Documentation
      Committee [IKDC]) will also be conducted at these times. Further, all patients will be asked
      to wear a tri-axial accelerometer to gain an objective measure of habitual physical activity
      (PA) and sedentary time and pattern for one week pre-surgery (5 weekdays and 2 weekend days),
      during the first and final week of the INTERVENTION/CONTROL and then again at 6 months post-
      INTERVENTION/CONTROL.

      The initial assessments at 10-weeks post-surgery will evaluate the efficacy of the
      contralateral training programme, specifically whether the training intervention on the
      non-injured leg elicited changes in the performance of the injured leg compared to the
      control group. The assessments at 6-months post-surgery will evaluate any carry-over effects
      of the contralateral training programme, specifically whether any changes in performance of
      the injured leg were retained at 6-months post-surgery compared to the control group.
      6-months post-surgery is currently the earliest opportunity when we would permit patients to
      return to sports and activities.

      ACL surgeries will be performed by the same three surgeons at the RJAH Orthopaedic Hospital
      throughout the study and according to standardised techniques and procedures.

      Sample size and data analysis:

      The means and standard deviations of the primary outcome measure (peak strength) and the
      correlation coefficient between baseline strength and 8-weeks of strength training, all
      needed to calculate the sample size, were based on previously accrued data from our
      laboratory on similar cohorts of ACL patients. Assuming the trial will be powered to detect a
      difference between the groups of 50N (12.5% of peak strength) with 80% at a two-sided p=0.05
      significance level, the trial will require 18 patients in each group assuming analysis will
      be by ANCOVA (Analysis of Covariance; see formula in Borm et al., 2007). Based on a drop-out
      rate of 20%, the trial will require a sample size of 22 patients per trial arm (44 patients
      in total).

      Patient recruitment Potential participants will be identified from records of patients listed
      for ACL surgery and during out-patient clinics. They will be approached by a member of the
      clinical trial team (consultants, registrars, physiotherapist, lead researcher). The study
      information and design will be explained to the patients meeting the inclusion criteria and
      who are interested. They will be given a patient information leaflet and informed consent
      form to take away with them. These patients will be contacted by phone by the physiotherapist
      or lead researcher at least 24-hours later to ascertain their verbal consent into the study
      and to arrange an appointment for an initial assessment. Patients will have the opportunity
      to ask any questions about the study at this stage also. Written informed consent will be
      obtained at the first appointment, prior to the initial assessment. Once consented in to the
      study, patients will be assigned a number. A master copy of individuals' unique
      identification number and all data will be held on a password-protected computer, stored in a
      locked cabinet, in a locked NHS research office.

      Data monitoring:

      Scheduled monthly meetings with the research team will enable monitoring of study progress.
      Quarterly meetings of the RJAH data monitoring group will provide independent monitoring of
      the study. No adverse advents are expected, however, ant will be recorded in the on-site file
      and reported immediately to the data monitoring group.
    

Intervention name(s): Contralateral Rehabilitation; Placebo flexibility exercise
Intervention type(s): Other; Other
Intervention description(s): Patients will undergo resistance training of the thigh musculature of the non-injured (contralateral) limb 3 times per week. The exercises will consist of unilateral: knee extensions; knee flexions and; leg-press, all performed on commercially-available resistance training machines. To optimise strength gains, patients will work to the 5 repetition-maximum rule (Kraemer et al. 2002); 3 sets of each exercise will be performed and a 2-minute rest will separate each set. Sessions will take no longer than 15-20 minutes, including rest.; Patients will perform 'placebo' flexibility training of the upper limb, which will involve a time-matched stretching programme targeting the latissimus dorsi, triceps brachii, biceps brachii, trapezius and pectoral muscles of both limbs. Each stretch will be performed twice, held for 20-30 seconds each time and will be followed by a 30-second rest (McCrary et al. 2015)
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Rehabilitation; Cross-education