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Prevention of Injuries by an Exercise Program – a RCT

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ClinicalTrials.gov Identifier: NCT00348647
Recruitment Status : Unknown
Verified December 2004 by Amager Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 4, 2006
Last Update Posted : July 4, 2006
Sponsor:
Information provided by:
Amager Hospital

Study Description
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Brief Summary:
Overuse injuries are a major concern for physical active individuals. Study hypothesis is that an exercise programme based on known intrinsic risk factors can prevent overuse injuries in soldiers undergoing basic military training.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Exertional Lower Leg Pain Behavioral: physical training program to prevent injuries Not Applicable

Detailed Description:

PURPOSE: Overuse injuries are a major concern for physical active individuals engaged in endurance type activities. This is especially true for soldiers during basic military training or subjects with a sedentary lifestyle taking up exercise to prevent disease, as they are vulnerable for sustaining an overuse injury. Contradictory to traumatic injuries, little is known about the prevention of overuse injuries using a training program. This study evaluates the preventive effect of a training program based on known intrinsic risk factors for the occurrence of anterior knee pain and shin pain in soldiers undergoing basic military training. We also evaluate the effect on physical performance.

METHODS: From December 2004 – March 2006 1000 soldiers undergoing basic military training divided into 24 platoons are cluster randomised into a prevention-training (PRE) group or a placebo-training (PLA) group. The PRE group will perform exercises based on known intrinsic risk factors namely strength, flexibility and coordination of the lower extremity, while the PLA group will perform exercises for the upper body. Both programmes consists of 5 exercises and will be performed 3 times a week during a 12 weeks period. All subjects will prospectively be examined by the same observer, who will be blinded to the allocation.

OUTCOME: primary outcome: reduction in anterior knee pain and shin pain.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Can Lower Extremity Overuse Injuries Be Prevented by an Exercise Program Aiming at Muscular Strength, Flexibility and Coordination – a RCT
Study Start Date : December 2004
Study Completion Date : March 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. reduction in anterior knee pain
  2. reduction in shin pain

Secondary Outcome Measures :
  1. reduktion in overuse injuries
  2. physical performance

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Basic military training in the Royal Danish Guards.
  • Passed military medical board.

Exclusion Criteria:

  • Injury before start of intervention
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348647


Sponsors and Collaborators
Amager Hospital
Investigators
Principal Investigator: Christoffer Brushoj, MD Amager Hospital DK-2300 Amager
More Information
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ClinicalTrials.gov Identifier: NCT00348647     History of Changes
Other Study ID Numbers: 2003-1-62
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: July 4, 2006
Last Verified: December 2004

Keywords provided by Amager Hospital:
Prevention
Exercise
Overuse
Anterior knee pain syndrome
 Exertional lower leg pain
Prospective
Risk factors
Hip

Additional relevant MeSH terms:
Patellofemoral Pain Syndrome
Joint Diseases
Musculoskeletal Diseases