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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
Amager Hospital
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 3, 2006
    Last Updated
    July 3, 2006
    Sponsor
    Amager Hospital
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    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

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    Prevention of Injuries by an Exercise Program - a RCT

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