Clinical trial NCT03080246: Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners
Official title: Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overuse Injury
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2017-03-15
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to look at the effect of strength training in preventing overuse injuries in female runners

Detailed description: This randomized clinical trial will compare the effects of 9-months of strength training to a control group on: (1) injury rates in female runners during the 9 month intervention period, and for 9 months after completing the intervention, and (2) on the potential mechanisms of injury including strength, joint and tissue loading, and psychosocial factors.

Eligibility criteria: Inclusion Criteria:

* Female civilian runners between 18-60 years old
* Run at least 5 miles per week for the past 6 months
* No overuse injuries in the past 6 months
* Plan to stay in the area for the next year and a half
* Live less than 30 miles from Wake Forest University or High Point University

Exclusion Criteria:

* Male
* Under age 18 and over age 60
* Chronic diseases, orthopedic conditions, past anterior cruciate ligament tears
* Currently pregnant or planning to conceive within the next 18 months
* Observed by study staff as unwilling to attend testing/intervention sessions
* Observed by study staff as unwilling to communicate via telephone and email regularly with study personnel
* Participated in formal strength training in the past 6 months
* Current active military or active military reserve

Primary outcomes:
measure: Incidence of Overuse Injury (Physical Exam/Injury Report Form)
timeFrame: Month 18
Secondary outcomes:
measure: Lower Extremity Muscular Strength (HUMAC norm isokinetic dynamometer)
timeFrame: Months 0, 9, and 18
measure: Biomechanical Joint Moments (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)
timeFrame: Month 0, 9, and 18
measure: Biomechanical Joint Forces (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)
timeFrame: Month 0, 9, and 18
measure: Biomechanical Joint Tissue Loading (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)
timeFrame: Month 0, 9, and 18
measure: Self-Efficacy (Adherence Self-Efficacy Questionnaire)
timeFrame: Months 0, 9, and 18
measure: Quality of Life (SF-12 Health Related Quality of Life Survey)
timeFrame: Months 0, 9, and 18
measure: Quality of Life (Satisfaction with Life Scale)
timeFrame: Months 0, 9, and 18
measure: Quality of Life (Positive and Negative Affect Scale)
timeFrame: Months 0, 9, and 18
measure: Quality of Life (State Trait Anxiety Inventory-S Scale)
timeFrame: Months 0, 9, and 18
measure: Quality of Life (Visual Analog Pain Scale)
timeFrame: Months 0, 9, and 18
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Stephen P Messier, PhD
role: PRINCIPAL_INVESTIGATOR
References: