Contact information
Type
Scientific
Primary contact
Mr Russell Coppack
ORCID ID
Contact details
Rehabilitation Division
Defence Medical Rehabilitation Centre
Headley Court
Epsom
KT18 6JW
United Kingdom
+44 (0)7717 212036
russ.coppack916@mod.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0603/40
Study information
Scientific title
An exercise protocol for the prevention of acute anterior knee pain (AKP) in military recruits undergoing phase 1 training: a single-blind cluster randomised controlled trial
Acronym
Study hypothesis
A targeted exercise intervention will result in a statistically significant reduction in the incidence of acute anterior knee pain (AKP), compared to non-intervention controls, in recruits undergoing phase 1 training.
Ethics approval
Ministry of Defence (MOD) Personnel Research Ethics Committee approved on the 10th February 2006 (ref: 0603/40)
Study design
Single-blind cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Anterior knee pain (AKP)/patellofemoral pain syndrome (PFPS)
Intervention
Injury prevention intervention:
The intervention group will undertake the existing common military training syllabus and the AKP preventative exercise protocol. This protocol will centre on the following components of training:
1. Quadriceps, hamstrings, gastrocnemius and iliotibial band (ITB) muscle stretching
2. Quadriceps, vastus medialis oblique (VMO) open and closed kinetic chain strengthening
3. Gluteal muscle strengthening
The intervention will be completed on average 7 times per week during the warm-up and warm-down of each scheduled physical training period.
Control group programme:
The control group will complete the same common military syllabus with existing 'general' warm-up and warm-down exercises.
'Time exposed' to training, in both the intervention and control arms of the study, was defined as the length of time an individual spent in training with his or her original training group free of AKP. Patients were thus censored at the point they were removed from training (various time-points through the 14-week training period). Participants who successfully completed training with their original troop were censored at the point of exit (14 weeks). There was no follow-up after the 14-week point.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Incident case of AKP occuring during the 14-week period of phase 1 training
Secondary outcome measures
Occupation outcome of training for each participant defined as:
1. Successful completion of training
2. Medical discharge (MD)
3. Discharge as of right (DAOR: a voluntary discharge at the request of the recruit)
4. Unfit for Army Service (UFAS: recruits incapable of meeting the training standards)
5. Back squadding (recruits held back in training)
6. Other (withdrawal from training for all other reasons)
All assessed throughout the entire 14-week trial period.
Overall trial start date
30/08/2006
Overall trial end date
01/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
British Army recruits (aged 17 - 25 years, either sex) undergoing phase 1 training will fulfil the eligibility criteria for inclusion in the trial if they exhibit signs and symptoms of AKP with no evidence of any other specific pathologic condition. The inclusion criteria is:
1. Anterior or retropatellar pain arising from at least two of the following: prolonged sitting, stair-climbing, squatting, running, kneeling, hopping/jumping
2. Insidious onset of symptoms unrelated to a traumatic incident
3. Presence of pain on palpation of the patellar facets, on step down from a step, or during a double-legged squat
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2762
Participant exclusion criteria
1. Signs and symptoms of meniscal or other intra-articular pathologic condition
2. Ligament laxity or tenderness
3. Tenderness over the patellar tendon, illiotibial band, or pes-anserinus tendons
4. Osgood-schlatters or Sinding Larsen-Johanssen syndromes
5. Knee joint effusion or hip/lumbar referred pain
6. History of patellar dislocation
7. Other structural damage to the knee
Recruitment start date
30/08/2006
Recruitment end date
01/10/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Rehabilitation Division
Epsom
KT18 6JW
United Kingdom
Sponsor information
Organisation
Army Recruitment Training Division (ARTD) (UK)
Sponsor details
c/o Lt. Col John Etherington
Director of Defence Rehabilitation (DDR)
Defence Medical Rehabilitation Centre (DMRC)
Headley Court
Epsom
KT18 6JW
United Kingdom
+44 (0)1372 381019
DMRC-DirectorDefenceRehab@mod.uk
Sponsor type
Other
Website
Funders
Funder type
Other
Funder name
Army Recruitment Training Division (ARTD) (UK) (ref: D/ATRA/5/22/7/12; dated 09 Sep 2005)
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
Results - basic reporting
Publication summary
2011 pilot study results in http://www.ncbi.nlm.nih.gov/pubmed/21212307
Publication citations
-
Pilot study results
Coppack RJ, Etherington J, Wills AK, The effects of exercise for the prevention of overuse anterior knee pain: a randomized controlled trial., Am J Sports Med, 2011, 39, 5, 940-948, doi: 10.1177/0363546510393269.