Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of prehabilitation on the outcome of anterior cruciate ligament reconstruction: a two centre prospective, single surgeon, randomly allocated study
Acronym
Study hypothesis
To determine whether prehabilitation would result in equal quadriceps strength 3 month post anterior cruciate ligament (ACL) reconstruction.
As of 20/09/2011 the anticipated end date for this trial has been extended from 30/06/2011 to 30/06/2012.
Ethics approval
1. Cappagh National Orthopaedic Hospital Research Ethics Committee approved on the 1st December 2009 (ref: JOB.10.2009.28)
2. Sports Surgery Clinic Research and Ethics Committee approved on the 8th February 2010
Study design
Single surgeon multicentre prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Anterior cruciate ligament tear
Intervention
This interventional trial will recruit 30 patients: 15 in the prehabilitation exercise group, 15 control patients recieving standard pre- and post-operative care. The prehabilitation group will recieve 6 weeks pre-operative physiotherapy programme comprising of 2 gym and 2 home sessions per week.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Isokinetic quadriceps strength testing
2. Magnetic resonance imaging cross-sectional area of the quadriceps (MRI CSA)
3. Physical performance test: single leg hop test and in-line lunge
4. Disease specific questionnaire: Modified Cincinnatti Knee Score, Tegner Lysholm Knee Score, Tegnaer Activity Scale
5. Muscle biopsy of quadriceps: looking for down-regulation of muscle atrophy genes and up-regulation in IGF-1 pathways in muscle hypertrophy
Patients will undergo all the above test at time of recruitment, 6 weeks post exercise and 3 months postoperatively.
6. Time to return to sports activities
Secondary outcome measures
1. To determine the effect of a pre-operative exercise programme on isokinetic hamstring strength
2. To assess the validity, reliability and responsiveness of:
2.1. Isokinetic dynamometry
2.2. Physical performance tests
2.3. Questionnaires
Overall trial start date
13/01/2011
Overall trial end date
30/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with isolated anterior cruciate ligament tear
2. Males aged 18 - 40 years
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
30
Participant exclusion criteria
1. Patients with age less than 18 or over 40 years
2. Patients living outside Greater Dublin area (for practical reasons regarding exercise supervision)
3. Patients with associated fractures, meniscal repair and collateral ligament injury
4. Patients with co-morbidities (contra-indication to relatively high physical exertion)
Recruitment start date
13/01/2011
Recruitment end date
30/06/2012
Locations
Countries of recruitment
Ireland
Trial participating centre
Cappagh National Orthopaedic Hospital
Dublin
11
Ireland
Sponsor information
Organisation
Cappagh National Orthopaedic Hospital (Ireland)
Sponsor details
Finglas
Dublin
11
Ireland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initated and funded (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23845398
Publication citations
-
Results
Shaarani SR, O'Hare C, Quinn A, Moyna N, Moran R, O'Byrne JM, Effect of prehabilitation on the outcome of anterior cruciate ligament reconstruction., Am J Sports Med, 2013, 41, 9, 2117-2127, doi: 10.1177/0363546513493594.