Prevention of Injuries by an Exercise Program – a RCT

Patellofemoral Pain Syndrome Clinical Trial

Official title:

Can Lower Extremity Overuse Injuries Be Prevented by an Exercise Program Aiming at Muscular Strength, Flexibility and Coordination – a RCT

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00348647
• Other study ID #: 2003-1-62
• Status: Active, not recruiting
• Phase: N/A
• First received: July 3, 2006
• Last updated: July 3, 2006
• Start date: December 2004
• Est. completion date: March 2006

Study information

• Verified date: December 2004
• Source: Amager Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 900
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Basic military training in the Royal Danish Guards.

• Passed military medical board.

Exclusion Criteria:

• Injury before start of intervention

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Exertional Lower Leg Pain
• Patellofemoral Pain Syndrome

Intervention

Behavioral:
• physical training program to prevent injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amager Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in anterior knee pain
Primary	reduction in shin pain
Secondary	reduktion in overuse injuries
Secondary	physical performance