Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04021576 |
| Other study ID # |
ISPA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2017 |
| Est. completion date |
February 28, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Balgrist University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
Description:
The primary objectives of this study are:
1. 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;
2. 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:
3. 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;
4. 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.
