Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02722876 |
| Other study ID # |
EFCOR001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 30, 2017 |
| Est. completion date |
July 8, 2019 |
Study information
| Verified date |
October 2020 |
| Source |
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
