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The Efficacy of Rehabilitation Exercise on the Non-operative Limb Following Anterior Cruciate Ligament Reconstruction (EFCOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02722876
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Tracking Information
First Submitted Date  ICMJE March 17, 2016
First Posted Date  ICMJE March 30, 2016
Last Update Posted Date April 17, 2020
Actual Study Start Date  ICMJE January 30, 2017
Actual Primary Completion Date January 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
Muscle Strength (peak force) [ Time Frame: 8-weeks post ACL-reconstruction ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • Muscle Strength (peak force) [ Time Frame: 6-months post ACL-reconstruction ]
  • Functional capability [ Time Frame: 8-weeks and 6-months post ACL-reconstruction ]
    1-legged hop for distance
  • Limb symmetry index [ Time Frame: 8-weeks and 6-months post ACL-reconstruction ]
    difference in muscle function between limbs
  • Patient perceived knee function [ Time Frame: 8-weeks and 6-months post ACL-reconstruction ]
    IKDC questionnaire
  • Physical activity (PA) [ Time Frame: 8-weeks and 6-months post ACL-reconstruction ]
    Objective measures of PA by accelerometry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Rehabilitation Exercise on the Non-operative Limb Following Anterior Cruciate Ligament Reconstruction
Official Title  ICMJE The EFficacy of COntralateral Muscle Rehabilitation Exercise Following Anterior Cruciate Ligament Reconstruction (EFCOR)
Brief 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 8-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 8-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 strength, 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Musculoskeletal System
Intervention  ICMJE
  • Other: Contralateral Rehabilitation
    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.
  • Other: Placebo flexibility exercise
    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)
Study Arms  ICMJE
  • Experimental: Contralateral rehabilitation
    8-weeks of resistance training of the non-operative limb following ACL reconstruction
    Intervention: Other: Contralateral Rehabilitation
  • Placebo Comparator: Placebo flexibility exercise
    8-weeks of 'placebo' flexibility training of the upper limb
    Intervention: Other: Placebo flexibility exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2016)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 8, 2019
Actual Primary Completion Date January 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Mentally mature
  • Listed for unilateral ACL reconstructive surgery following informed surgical consent
  • Autologous graft tissue; either patella tendon or semitendinosus and gracilis from the ipsilateral leg

Exclusion Criteria:

  • Patients under 16 or over 50 years of age
  • Patients with systemic pathologies (e.g. renal failure)
  • Symptomatic non-operative knee
  • Additional ligament injuries, meniscal transplant and,or, articular cartilage repair to the operative knee
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02722876
Other Study ID Numbers  ICMJE EFCOR001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual data will not be shared
Responsible Party Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Study Sponsor  ICMJE Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrea Bailey, PhD The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
PRS Account Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP