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

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ClinicalTrials.gov Identifier: NCT03080246
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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

Condition or disease Intervention/treatment Phase
Overuse Injury Behavioral: Strength Training Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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 3 days per week for about an hour each day. 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 will go on for 9 months, followed by another 9 months of follow-up via email and 2 group meetings at Fleet Feet (at 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 at Fleet Feet (at months 1, 3, 6, 12, and 15). After the 18 months, they will be offered a free 6-week strength training program at the Clinical Research Center.



Primary Outcome Measures :
  1. Incidence of Overuse Injury (Physical Exam/Injury Report Form) [ Time Frame: Month 18 ]
    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.


Secondary Outcome Measures :
  1. Lower Extremity Muscular Strength (HUMAC norm isokinetic dynamometer) [ Time Frame: Months 0, 9, and 18 ]
    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.

  2. Biomechanical Joint Moments (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis) [ Time Frame: Month 0, 9, and 18 ]
    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.

  3. Biomechanical Joint Forces (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis) [ Time Frame: Month 0, 9, and 18 ]
    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.

  4. Biomechanical Joint Tissue Loading (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis) [ Time Frame: Month 0, 9, and 18 ]
    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.

  5. Self-Efficacy (Adherence Self-Efficacy Questionnaire) [ Time Frame: Months 0, 9, and 18 ]
    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

  6. Quality of Life (SF-12 Health Related Quality of Life Survey) [ Time Frame: Months 0, 9, and 18 ]
    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

  7. Quality of Life (Satisfaction with Life Scale) [ Time Frame: Months 0, 9, and 18 ]
    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

  8. Quality of Life (Positive and Negative Affect Scale) [ Time Frame: Months 0, 9, and 18 ]
    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

  9. Quality of Life (State Trait Anxiety Inventory-S Scale) [ Time Frame: Months 0, 9, and 18 ]
    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

  10. Quality of Life (Visual Analog Pain Scale) [ Time Frame: Months 0, 9, and 18 ]
    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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080246


Contacts
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Contact: Stephen P Messier, PhD 3367585849 messier@wfu.edu
Contact: Monica J Love, MS 3367583075 munseymj@wfu.edu

Locations
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United States, North Carolina
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27109
Contact: Stephen P Messier, PhD    336-758-5849    messier@wfu.edu   
Contact: Monica J Love, MS    3367583075    munseymj@wfu.edu   
Principal Investigator: Stephen P Messier, PhD         
Sponsors and Collaborators
Wake Forest University Health Sciences
U.S. Army Medical Research and Development Command
Investigators
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Principal Investigator: Stephen P Messier, PhD Wake Forest University

Additional Information:
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03080246     History of Changes
Other Study ID Numbers: IRB00034222
W81XWH-16-1-0001 ( Other Identifier: Army Med R & D Command )
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cumulative Trauma Disorders
Wounds and Injuries
Sprains and Strains