Fitness- and Health-related Effects of a Sports Injury Prevention Program in Competitive Alpine Skiers (ISPA)
Primary Purpose
Athletics
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
preventative training program
Sponsored by
About this trial
This is an interventional prevention trial for Athletics
Eligibility Criteria
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
Sites / Locations
- Balgrist University Hospital Balgrist Move>Med
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention
control
Arm Description
preventative training program
no such training
Outcomes
Primary Outcome Measures
Change from baseline to 12 months maximal eccentric hamstring strength
tested by using the NordBord
Change from baseline to 12 months axis-stability
assessed by biomechanical measurement technology
Change from baseline to 12 months hip-stability
assessed by biomechanical measurement technology
Change from baseline to 12 months core-stability
assessed by biomechanical measurement technology
Change from baseline to 12 months general fitness-related factors
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")
occurring health problems
Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire
Secondary Outcome Measures
smartphone enabled training and injury prevention program
senor-based activity measurements
Full Information
NCT ID
NCT04021576
First Posted
July 12, 2019
Last Updated
March 1, 2023
Sponsor
Balgrist University Hospital
Collaborators
Swiss National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04021576
Brief Title
Fitness- and Health-related Effects of a Sports Injury Prevention Program in Competitive Alpine Skiers
Acronym
ISPA
Official Title
Fitness- and Health-related Effects of a Sports Injury Prevention Program in Competitive Alpine Skiers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Balgrist University Hospital
Collaborators
Swiss National Science Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Intervention with historical control group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
preventative training program
Arm Title
control
Arm Type
No Intervention
Arm Description
no such training
Intervention Type
Other
Intervention Name(s)
preventative training program
Intervention Description
complementary training of leg-, hip- and core-strength/stability
Primary Outcome Measure Information:
Title
Change from baseline to 12 months maximal eccentric hamstring strength
Description
tested by using the NordBord
Time Frame
assessed before and after a 12-month preventative training intervention
Title
Change from baseline to 12 months axis-stability
Description
assessed by biomechanical measurement technology
Time Frame
assessed before and after a 12-month preventative training intervention
Title
Change from baseline to 12 months hip-stability
Description
assessed by biomechanical measurement technology
Time Frame
assessed before and after a 12-month preventative training intervention
Title
Change from baseline to 12 months core-stability
Description
assessed by biomechanical measurement technology
Time Frame
assessed before and after a 12-month preventative training intervention
Title
Change from baseline to 12 months general fitness-related factors
Description
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")
Time Frame
assessed before and after a 12-month preventative training intervention
Title
occurring health problems
Description
Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire
Time Frame
2-weekly
Secondary Outcome Measure Information:
Title
smartphone enabled training and injury prevention program
Description
senor-based activity measurements
Time Frame
during 12-month preventative training intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörg Spörri, PD Dr.
Organizational Affiliation
Balgrist University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balgrist University Hospital Balgrist Move>Med
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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Fitness- and Health-related Effects of a Sports Injury Prevention Program in Competitive Alpine Skiers
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