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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03408925
Other study ID # 4-1645/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 27, 2018
Est. completion date October 15, 2018

Study information

Verified date February 2020
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The high physical load associated with running through uneven terrain contributes to that orienteerers are exposed to high injury risk, where the majority of injuries located in the lower extremities. Specific training programmes have been effective at reducing injury risk in sports. Yet, not trial has been conducted in elite orienteering. 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, with three difficult levels intensified every second week over the first four weeks, targeting strength, flexibility and coordination of the lower extremity. The exercises are completed 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. Participants will be recruited in January-February 2018. The intervention starts in February 2018 and data collection will be completed in June 2018. Data analyses are expected to be completed in October-November 2018.

Due to high injury risk and lack of injury prevention trials in orienteering, a RCT investigating the effect of a specific exercise program on the incidence of injuries in the lower extremity, is warranted. The results of this trial will be beneficial to orienteerers, clubs, federations and increase our understanding on how lower extremity injuries can be prevented in a physically challenging sport.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date October 15, 2018
Est. primary completion date June 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

Adult elite orienteerers Aged 18-40 years Participating in the highest national orienteering league (Swedish League) Participant inclusion criteria - Age group: Adult Participant inclusion criteria - Gender: Both

Exclusion Criteria:

Injured adult elite orienteerers not able to perform baseline tests

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise program
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.

Locations

Country Name City State
Sweden Karolinska Institutet Huddinge

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lower extremity injury Number of substantial injuries in the lower extremity March-June 2018 (10 weeks)
Secondary Ankle sprain Incidence of ankle sprains injuries March-June 2018 (10 weeks)
Secondary Substantial injury The average substantial injury prevalence March-June 2018 (10 weeks)
See also
  Status Clinical Trial Phase
Completed NCT03335657 - Improving Recovery After Orthopaedic Trauma: Cognitive-Behavioral Based Physical Therapy (CBPT) N/A