NCT03408925

Brief Summary

The aim of this study is to investigate the effect a specific exercise program on the incidence of injuries in the lower extremity. 72 elite orienteerers, aged 18-40 years, are allocated to an intervention or control group. The intervention group performs four specific exercises, four times a week (10 minutes per session) in conjunction with normal training. Injury data are collected every second week using valid injury questionnaire distributed by text messages over 14 weeks. Primary outcome is number of substantial injuries in the lower extremity. Secondary outcomes are incidence of ankle sprains and the average substantial injury prevalence across the 10 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 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

First Submitted

Initial submission to the registry

January 16, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 27, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

January 16, 2018

Last Update Submit

February 18, 2020

Conditions

Keywords

elite orienteering

Outcome Measures

Primary Outcomes (1)

  • Lower extremity injury

    Number of substantial injuries in the lower extremity

    March-June 2018 (10 weeks)

Secondary Outcomes (2)

  • Ankle sprain

    March-June 2018 (10 weeks)

  • Substantial injury

    March-June 2018 (10 weeks)

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention consists of an exercise program developed by the medical team of the National Federation of Orienteering. Specifically, it consists of four exercises targeting strength, flexibility and coordination of the lower extremity. The orienteerers are asked to perform the exercises four times a week throughout the entire study period. The exercises are heel rises, runners pose, single leg stance and one-leg jumps with three difficult levels aiming to mainly improve lower extremity strength and neuromuscular function (online supplement). Each second week the exercises' difficulty level is increased.

Other: Exercise program

Control

NO INTERVENTION

Normal training, no intervention

Interventions

The orienteerers are asked to perform specific exercises four times a week throughout the entire study period. The exercises are heel rises, runners pose, single leg stance and one-leg jumps with three difficult levels aiming to mainly improve lower extremity strength and neuromuscular function. Each second week the exercises' difficulty level is increased.

Intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • Injured adult elite orienteerers not able to perform baseline tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Huddinge, 141 52, Sweden

Location

Related Publications (1)

  • von Rosen P, Halvarsson B. Preventing lower extremity injury in elite orienteerers: study protocol for a randomised controlled trial. BMJ Open Sport Exerc Med. 2018 Apr 20;4(1):e000347. doi: 10.1136/bmjsem-2018-000347. eCollection 2018.

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Philip von Rosen

    Karolinska Insitute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Test assessors and data collectors will be blinded to treatment allocation. The randomized phase will be unblinded after 14 weeks of data collection and the long-term follow-up (4 months) will be conducted by test assessors blinded to treatment allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: RCT, two groups (intervention/control)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 24, 2018

Study Start

February 27, 2018

Primary Completion

June 20, 2018

Study Completion

October 15, 2018

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations