Patellofemoral Pain SyndromeNCT00348647
Prevention of Injuries by an Exercise Program - a RCT
A study testing physical training program to prevent injuries in people with Patellofemoral Pain Syndrome and Exertional Lower Leg Pain, run by Amager Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome, Exertional Lower Leg Pain
- What is being tested?
- physical training program to prevent injuries
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Basic military training in the Royal Danish Guards.
- Passed military medical board.
Who cannot join
- Injury before start of intervention
About this study
Official title: Can Lower Extremity Overuse Injuries Be Prevented by an Exercise Program Aiming at Muscular Strength, Flexibility and Coordination - a RCT
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.
Read the 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.
- Being tested
- physical training program to prevent injuries
- Keywords
- Prevention, Exercise, Overuse, Anterior knee pain syndrome, Exertional lower leg pain, Prospective, Risk factors, Hip
- Medical subject headings
- Patellofemoral Pain Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical training program to prevent injuriesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in anterior knee pain
reduction in shin pain
Secondary outcomes (2)
reduktion in overuse injuries
physical performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startDec 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 900 participants
Sponsor and investigators
- Lead sponsor
- Amager Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Christoffer Brushoj, MD, Principal investigator, Amager Hospital DK-2300 Amager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348647
- Sponsor's protocol ID
- 2003-1-62
- Status last verified
- Dec 2004
- First submitted
- 3 Jul 2006
- Last updated
- 4 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Lower Extremity Overuse Injuries Be Prevented by an Exercise Program Aiming at Muscular Strength, Flexibility and Coordination - a RCT
- ClinicalTrials.gov ID
- NCT00348647
- Acronym / sponsor ID
- 2003-1-62
- Keywords
- Prevention, Exercise, Overuse, Anterior knee pain syndrome, Exertional lower leg pain, Prospective, Risk factors, Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants
- Lead sponsor
- Amager HospitalUniversity, hospital or other
- Study start
- Dec 2004
- Study completion
- Mar 2006
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Basic military training in the Royal Danish Guards.
- Passed military medical board.
Key exclusion criteria (1 listed)
- Injury before start of intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical training program to prevent injuries | Behavioural | – |
Primary outcome
reduction in anterior knee pain
reduction in shin pain
2 secondary outcomes
reduktion in overuse injuries
physical performance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoffer Brushoj, MD principal investigator
Amager Hospital DK-2300 Amager
Questions about this trial
What is this clinical trial studying?
A study testing physical training program to prevent injuries in people with Patellofemoral Pain Syndrome and Exertional Lower Leg Pain, run by Amager Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in anterior knee pain. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2006.