The effect of prehabilitation on the outcome of anterior cruciate ligament reconstruction
| ISRCTN | ISRCTN60779921 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60779921 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Cappagh National Orthopaedic Hospital
Finglas
Dublin
11
Ireland
Study information
| Study design | Single surgeon multicentre prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 13/01/2011 |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 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
11
Ireland
Sponsor information
Cappagh National Orthopaedic Hospital (Ireland)
Hospital/treatment centre
Hospital/treatment centre
Finglas
Dublin
11
Ireland
| Website | http://www.cappagh.ie |
|---|---|
"ROR" |
https://ror.org/03vc5bf16 |
Funders
Funder type
Other
Investigator initated and funded (Ireland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
