- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04021576
Fitness- and Health-related Effects of a Sports Injury Prevention Program in Competitive Alpine Skiers (ISPA)
Overall Goal: Elaboration of an evidence-based, national prevention strategy to protect the health of competitive alpine skiers, with a particular focus on youth athletes.
Background: Competitive alpine skiing has a relatively high injury risk. 60% of all athletes suffer from a severe knee injury in the early stages of their career, and 20% struggle with recurrent overuse problems of the knee and lower back.
Research Aims: (1) to investigate the effects of a 12-month sports injury prevention program on training attitudes, eccentric hamstring strength, leg axis-/hip-/core-stability and general fitness in competitive alpine skiers; (2) to assess the effectiveness the aforementioned prevention program to lower the occurring health problems in competitive alpine skiers; (3) to identify different pain conditions (knee, back, no pain) based on data measured with smartphones; and (4) to investigate the agreement of self-reported questionnaire data with measured smartphone data and pain as an affecting factor.
Methods: 12-month intervention a sports injury prevention program, a prospective health- and training/activity-monitoring, as well as assessments of eccentric hamstring strength, leg axis/hip/core stability and general fitness at baseline and follow-up.
Study Overview
Detailed Description
The primary objectives of this study are:
- to investigate the effects of a sports injury prevention program on train-ing attitudes, eccentric hamstring strength, leg axis-/hip-/core-stability and general fitness in competitive alpine skiers;
to assess the effectiveness the prevention program to lower the occur-ring health problems (i.e. traumatic injuries, overuse injuries and illnesses) in competitive alpine skiers.
The secondary objectives of this study are:
- to investigate the agreement between self-reported questionnaire data with unobtrusively measured smartphone data (i.e. sensor-based activity data) to monitor the prevention program;
- to identify athletes at risk for developing pain and injury based on digitally acquired data (questionnaires and activity sensor data).
The primary study outcomes are the changes in training attitudes, maximal eccentric hamstring strength, leg axis-/hip-/core-stability, general fitness-related factors and the occurring health problems in competitive youth alpine skiers over a 12-month intervention period. These outcomes are assessed by established methods of strength testing, neuromuscular screening, and load- and health-monitoring.
The secondary outcome is a smartphone enabled training and injury prevention program for skiing athletes.
Study design: Medical Training Therapy (MTT) Intervention with historical control Group
Methods and procedures:
Fitness- and health-related factors are assessed before and after a 12-month observational period and before and after a 12-month preventative training intervention period.
Maximal eccentric hamstring strength is tested by using the NordBord (Inc. VALD Performance, AU).
Leg axis-/hip-/core-stability related measures are assessed by biomechani-cal measurement technologies, such as Vicon Vero (Inc. Vicon Motion Sys-tems Ltd, UK), mobile 2D force plates (MLD, Inc. SP Sportdiagnosegeräte GmbH, AT), mobile 3D force plates (Inc. Kistler Group, SUI) and surface electromyography (EMG) (aktos, Inc. Myon AG, SUI).
General fitness-related factors are quantified by the Swiss-Ski Power Test (incl. the tasks "swiss cross", "push up", "5-jump", "standing long jump", "twist test", "obstacle course", "high box jump" and "12' run").
The athletes' training loads/activities are monitored using custom question-naires and measurements obtained through a smartphone (i.e. activity sen-sors).
The athletes' health is monitored by the OSTRC questionnaire. The athletes' biological age/maturity offset is estimated according to the non-invasive, anthropometric-based method of Mirwald et al.
Intervention: The intervention (i.e. the preventative training program) includes a specific, complementary training of leg-, hip- and core-strength/stability and will be conducted over an intervention period of 12 months. The control interven-tion, compromises no such training program.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zürich, Switzerland, 8008
- Balgrist University Hospital Balgrist Move>Med
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- competitive athletes that are part of a Swiss-Ski development program
- Written informed consent by the participant (or parents)
Exclusion Criteria:
- No written informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention
preventative training program
|
complementary training of leg-, hip- and core-strength/stability
|
No Intervention: control
no such training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to 12 months maximal eccentric hamstring strength
Time Frame: assessed before and after a 12-month preventative training intervention
|
tested by using the NordBord
|
assessed before and after a 12-month preventative training intervention
|
Change from baseline to 12 months axis-stability
Time Frame: assessed before and after a 12-month preventative training intervention
|
assessed by biomechanical measurement technology
|
assessed before and after a 12-month preventative training intervention
|
Change from baseline to 12 months hip-stability
Time Frame: assessed before and after a 12-month preventative training intervention
|
assessed by biomechanical measurement technology
|
assessed before and after a 12-month preventative training intervention
|
Change from baseline to 12 months core-stability
Time Frame: assessed before and after a 12-month preventative training intervention
|
assessed by biomechanical measurement technology
|
assessed before and after a 12-month preventative training intervention
|
Change from baseline to 12 months general fitness-related factors
Time Frame: assessed before and after a 12-month preventative training intervention
|
quantified by the Swiss-Ski Power Test (incl.
the tasks "swiss cross", "push up", "5-jump", "standing long jump", "twist test", "obstacle course", "high box jump" and "12' run")
|
assessed before and after a 12-month preventative training intervention
|
occurring health problems
Time Frame: 2-weekly
|
Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire
|
2-weekly
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
smartphone enabled training and injury prevention program
Time Frame: during 12-month preventative training intervention
|
senor-based activity measurements
|
during 12-month preventative training intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jörg Spörri, PD Dr., Balgrist University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISPA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Athletics
-
Universidad de MurciaCompletedSports Physical Therapy | Athletics InjurySpain
-
Centre Hospitalier Universitaire de Saint EtienneCompletedWounds and Injuries | Athletics | Prevention ProgramFrance
-
Universidad de MurciaUniversidad Católica San Antonio de MurciaCompletedPerformance | Sports Physical Therapy | AthleticsSpain
-
Linkoeping UniversityCompleted
Clinical Trials on preventative training program
-
Mayo ClinicNational Cancer Institute (NCI)CompletedMalignant NeoplasmUnited States
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Baylor College of MedicineNational Cancer Institute (NCI)UnknownNon-Melanomatous Skin CancerUnited States
-
NHS FifeUniversity of TurkuUnknownDental Caries | Oral Microbial ColonizationUnited Kingdom
-
Education University of Hong KongNot yet recruiting
-
Universidad Pablo de OlavideUniversity of SevilleCompletedObesity | Overweight and Obesity | Overweight or ObesitySpain
-
Philip Morris Products S.A.CompletedSmoking | Exercise CapacityGermany
-
Chang Gung Memorial HospitalCompleted
-
University GhentSpecial Research Fund, BelgiumCompletedChronical Rotator Cuff TendinopathyBelgium
-
BaycrestSunnybrook Health Sciences CentreUnknownTransient Ischemic Attack | Mild Stroke | Ischemic White Matter Disease | Stroke RiskCanada