Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners (STARS)

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

Study Overview

• Status: Completed
• Conditions: Overuse Injury
• Intervention / Treatment: Behavioral: Strength Training Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27109
      • Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Strength Training Group; This group will begin coming to the Clinical Research Center (near the undergraduate campus of Wake Forest University) for exercise classes 2-3 days per week for about an hour each day. The investigators also have a site on High Point University's campus. The class will consist of a 10-minute warm-up, a 20-minute strength training period, 15-minutes of neuromuscular (balance/coordination) training, and a 15-minute cool down. These regular exercise classes at Wake Forest and High Point University will go on for 9 months, followed by another 9 months of option to continue at facility, plus follow-up via email and 2 group meetings/runs at Fleet Feet (at around months 12 and 15).	Behavioral: Strength Training Exercise
No Intervention: Running Group; This group will be observed as they follow their usual run-training routine over the course of 18 months. Emails will be sent biweekly for 18 months to update the research team on injury/training status. The group will attend 5 group meetings/runs at Fleet Feet (at around months 1, 3, 6, 12, and 15). After the 18 months, the participants will be offered a free 8-week strength training program at the Clinical Research Center or High Point University.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Overuse Injury (Physical Exam/Injury Report Form)	To compare the effects of a 9-month strength training program to a control group on the incidence of overuse, lower extremity, running injuries in female adult recreational and competitive runners during and 9 months subsequent to the training period.	Month 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower Extremity Muscular Strength (HUMAC norm isokinetic dynamometer)	To compare the effects of 9-months of strength training to a control group on lower extremity muscular strength at the conclusion and 9 months subsequent to completion of the intervention.	Months 0, 9, and 18
Biomechanical Joint Moments (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)	To compare the effects of 9-months of strength training to a control group on hip, knee, and ankle joint moments during running at the conclusion and 9 months subsequent to completion of the intervention.	Month 0, 9, and 18
Biomechanical Joint Forces (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)	To compare the effects of 9-months of strength training to a control group on knee and ankle compressive and shear bone-on-bone joint forces during running at the conclusion and 9 months subsequent to completion of the intervention.	Month 0, 9, and 18
Biomechanical Joint Tissue Loading (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)	To compare the effects of 9-months of strength training to a control group on joint tissue loading during running at the conclusion and 9 months subsequent to completion of the intervention.	Month 0, 9, and 18
Self-Efficacy (Adherence Self-Efficacy Questionnaire)	To compare the effects of 9-months of strength training to a control group on performance self-efficacy at the conclusion and 9 months subsequent to completion of the intervention	Months 0, 9, and 18
Quality of Life (SF-12 Health Related Quality of Life Survey)	To compare the effects of 9-months of strength training to a control group on health-related quality of life at the conclusion and 9 months subsequent to completion of the intervention	Months 0, 9, and 18
Quality of Life (Satisfaction with Life Scale)	To compare the effects of 9-months of strength training to a control group on health-related quality of life at the conclusion and 9 months subsequent to completion of the intervention	Months 0, 9, and 18
Quality of Life (Positive and Negative Affect Scale)	To compare the effects of 9-months of strength training to a control group on health-related quality of life at the conclusion and 9 months subsequent to completion of the intervention	Months 0, 9, and 18
Quality of Life (State Trait Anxiety Inventory-S Scale)	To compare the effects of 9-months of strength training to a control group on health-related quality of life at the conclusion and 9 months subsequent to completion of the intervention	Months 0, 9, and 18
Quality of Life (Visual Analog Pain Scale)	To compare the effects of 9-months of strength training to a control group on health-related quality of life at the conclusion and 9 months subsequent to completion of the intervention	Months 0, 9, and 18

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: U.S. Army Medical Research and Development Command

Publications and helpful links

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sprains and Strains; Wounds and Injuries; Cumulative Trauma Disorders
• Other Study ID Numbers: IRB00034222; W81XWH-16-1-0001 (Other Identifier: Army Med R & D Command)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No