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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

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

NCT ID

NCT00348647

First Posted

July 3, 2006

Last Updated

July 3, 2006

Sponsor

Amager Hospital

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

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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