Condition category
Injury, Occupational Diseases, Poisoning
Date applied
16/03/2010
Date assigned
26/04/2010
Last edited
22/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.armedforces.co.uk/army/listings/l0136.html

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

  1. 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.

Additional files

Editorial Notes