Prevention of Injuries by an Exercise Program – a RCT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by Amager Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Amager Hospital
ClinicalTrials.gov Identifier:
NCT00348647
First received: July 3, 2006
Last updated: NA
Last verified: December 2004
History: No changes posted
  Purpose

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 Intervention
Patellofemoral Pain Syndrome
Exertional Lower Leg Pain
Behavioral: physical training program to prevent injuries

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Amager Hospital:

Primary Outcome Measures:
  • reduction in anterior knee pain
  • reduction in shin pain

Secondary Outcome Measures:
  • reduktion in overuse injuries
  • physical performance

Estimated Enrollment: 900
Study Start Date: December 2004
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348647

Sponsors and Collaborators
Amager Hospital
Investigators
Principal Investigator: Christoffer Brushoj, MD Amager Hospital DK-2300 Amager
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00348647     History of Changes
Other Study ID Numbers: 2003-1-62
Study First Received: July 3, 2006
Last Updated: July 3, 2006
Health Authority: Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Somatoform Disorders
Patellofemoral Pain Syndrome
Wounds and Injuries
Mental Disorders
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 18, 2014