Prevention of Injuries by an Exercise Program - a RCT
Primary Purpose
Patellofemoral Pain Syndrome, Exertional Lower Leg Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physical training program to prevent injuries
Sponsored by
About this trial
This is an interventional prevention trial for Patellofemoral Pain Syndrome focused on measuring Prevention, Exercise, Overuse, Anterior knee pain syndrome, Exertional lower leg pain, Prospective, Risk factors, Hip
Eligibility Criteria
Inclusion Criteria: Basic military training in the Royal Danish Guards. Passed military medical board. Exclusion Criteria: Injury before start of intervention
Sites / Locations
Outcomes
Primary Outcome Measures
reduction in anterior knee pain
reduction in shin pain
Secondary Outcome Measures
reduktion in overuse injuries
physical performance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00348647
Brief Title
Prevention of Injuries by an Exercise Program - a RCT
Official Title
Can Lower Extremity Overuse Injuries Be Prevented by an Exercise Program Aiming at Muscular Strength, Flexibility and Coordination - a RCT
Study Type
Interventional
2. Study Status
Record Verification Date
December 2004
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Amager Hospital
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome, Exertional Lower Leg Pain
Keywords
Prevention, Exercise, Overuse, Anterior knee pain syndrome, Exertional lower leg pain, Prospective, Risk factors, Hip
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
900 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
physical training program to prevent injuries
Primary Outcome Measure Information:
Title
reduction in anterior knee pain
Title
reduction in shin pain
Secondary Outcome Measure Information:
Title
reduktion in overuse injuries
Title
physical performance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Basic military training in the Royal Danish Guards.
Passed military medical board.
Exclusion Criteria:
Injury before start of intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoffer Brushoj, MD
Organizational Affiliation
Amager Hospital DK-2300 Amager
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Prevention of Injuries by an Exercise Program - a RCT
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