NCT04021576

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

4.4 years

First QC Date

July 12, 2019

Last Update Submit

March 1, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • Change from baseline to 12 months maximal eccentric hamstring strength

    tested by using the NordBord

    assessed before and after a 12-month preventative training intervention

  • Change from baseline to 12 months axis-stability

    assessed by biomechanical measurement technology

    assessed before and after a 12-month preventative training intervention

  • Change from baseline to 12 months hip-stability

    assessed by biomechanical measurement technology

    assessed before and after a 12-month preventative training intervention

  • Change from baseline to 12 months core-stability

    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

    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

    Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire

    2-weekly

Secondary Outcomes (1)

  • smartphone enabled training and injury prevention program

    during 12-month preventative training intervention

Study Arms (2)

intervention

EXPERIMENTAL

preventative training program

Other: preventative training program

control

NO INTERVENTION

no such training

Interventions

complementary training of leg-, hip- and core-strength/stability

intervention

Eligibility Criteria

Age13 Years - 36 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • competitive athletes that are part of a Swiss-Ski development program
  • Written informed consent by the participant (or parents)

You may not qualify if:

  • No written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital Balgrist Move>Med

Zurich, 8008, Switzerland

Location

Study Officials

  • Jörg Spörri, PD Dr.

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Intervention with historical control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 16, 2019

Study Start

October 1, 2017

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations