AthleticsISPANCT04021576
Fitness- and Health-related Effects of a Sports Injury Prevention Program in Competitive Alpine Skiers
A study testing preventative training program in people with Athletics, run by Balgrist University Hospital at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletics
- What is being tested?
- preventative training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2017to 28 Feb 2022
- 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 13 to 36 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- competitive athletes that are part of a Swiss-Ski development program
- Written informed consent by the participant (or parents)
Who cannot join
- No written informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist University Hospital Balgrist Move>Med
Zurich, 8008
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Athletics
- Being tested
- preventative training program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preventative training programOther
complementary training of leg-, hip- and core-strength/stability
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | preventative training program Receives: Other: preventative training program |
| control | No intervention | no such training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 12 months maximal eccentric hamstring strength
tested by using the NordBord
Measured: assessed before and after a 12-month preventative training intervention
Change from baseline to 12 months axis-stability
assessed by biomechanical measurement technology
Measured: assessed before and after a 12-month preventative training intervention
Change from baseline to 12 months hip-stability
assessed by biomechanical measurement technology
Measured: assessed before and after a 12-month preventative training intervention
Change from baseline to 12 months core-stability
assessed by biomechanical measurement technology
Measured: assessed before and after a 12-month preventative training intervention
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")
Measured: assessed before and after a 12-month preventative training intervention
occurring health problems
Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire
Measured: 2-weekly
Secondary outcomes (1)
smartphone enabled training and injury prevention program
senor-based activity measurements
Measured: during 12-month preventative training intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Oct 2017
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthleticsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Intervention with historical control group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Joerg Spoerri, Balgrist University Hospital
- Investigators
- Jörg Spörri, PD Dr., Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021576
- Sponsor's protocol ID
- ISPA
- Acronym
- ISPA
- Status last verified
- Mar 2023
- First submitted
- 12 Jul 2019
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitness- and Health-related Effects of a Sports Injury Prevention Program in Competitive Alpine Skiers
- ClinicalTrials.gov ID
- NCT04021576
- Acronym / sponsor ID
- ISPA / ISPA
- Conditions
- Athletics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 16 Jul 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention with historical control group
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: preventative training programpreventative training program |
| control | No intervention | –no such training |
Who may qualify
- Ages
- 13 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- competitive athletes that are part of a Swiss-Ski development program
- Written informed consent by the participant (or parents)
Key exclusion criteria (1 listed)
- No written informed consent
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 |
|---|---|---|
| preventative training programcomplementary training of leg-, hip- and core-strength/stability | Other | intervention |
Primary outcome
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
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
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
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
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")
occurring health problems
Time frame: 2-weekly
Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire
1 secondary outcome
smartphone enabled training and injury prevention program
Time frame: during 12-month preventative training intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Jörg Spörri, PD Dr. principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preventative training program in people with Athletics, run by Balgrist University Hospital at 1 site in Switzerland.
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: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline to 12 months maximal eccentric hamstring strength (time frame: assessed before and after a 12-month preventative training intervention). The study lists 6 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 3 Mar 2023.