The effect of prehabilitation on the outcome of anterior cruciate ligament reconstruction

ISRCTN	ISRCTN60779921
DOI	https://doi.org/10.1186/ISRCTN60779921
Protocol serial number	N/A
Sponsor	Cappagh National Orthopaedic Hospital (Ireland)
Funder	Investigator initated and funded (Ireland)

Submission date: 12/01/2011
Registration date: 31/01/2011
Last edited: 30/07/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Shahril Shaarani
Scientific

Cappagh National Orthopaedic Hospital
Finglas
Dublin
11
Ireland

Study information

Primary study design	Interventional
Study design	Single surgeon multicentre prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The effect of prehabilitation on the outcome of anterior cruciate ligament reconstruction: a two centre prospective, single surgeon, randomly allocated study
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	30
Key inclusion criteria	1. Patients with isolated anterior cruciate ligament tear 2. Males aged 18 - 40 years
Key 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)
Date of first enrolment	13/01/2011
Date of final enrolment	30/06/2012

Locations

Countries of recruitment

Ireland

Study participating centre

Cappagh National Orthopaedic Hospital

Dublin
11
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes