An exercise protocol for the prevention of acute anterior knee pain (AKP) in military recruits undergoing phase 1 training

ISRCTN	ISRCTN61493628
DOI	https://doi.org/10.1186/ISRCTN61493628
Secondary identifying numbers	0603/40

Submission date: 16/03/2010
Registration date: 26/04/2010
Last edited: 22/07/2013

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 Russell Coppack
Scientific

Rehabilitation Division
Defence Medical Rehabilitation Centre
Headley Court
Epsom
KT18 6JW
United Kingdom

Phone	+44 (0)7717 212036
Email	russ.coppack916@mod.uk

Study information

Study design	Single-blind cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Ministry of Defence (MOD) Personnel Research Ethics Committee approved on the 10th February 2006 (ref: 0603/40)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	30/08/2006
Completion date	01/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	2762
Key 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
Key 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
Date of first enrolment	30/08/2006
Date of final enrolment	01/10/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Rehabilitation Division

Epsom
KT18 6JW
United Kingdom

Sponsor information

Army Recruitment Training Division (ARTD) (UK)
Other

c/o Lt. Col John Etherington
Director of Defence Rehabilitation (DDR)
Defence Medical Rehabilitation Centre (DMRC)
Headley Court
Epsom
KT18 6JW
United Kingdom

Phone	+44 (0)1372 381019
Email	DMRC-DirectorDefenceRehab@mod.uk
Website	http://www.armedforces.co.uk/army/listings/l0136.html

Funders

Funder type

Other

Army Recruitment Training Division (ARTD) (UK) (ref: D/ATRA/5/22/7/12; dated 09 Sep 2005)

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	pilot study results	01/05/2011		Yes	No