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

Primary Purpose

Overuse Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strength Training Exercise
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overuse Injury

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Wake Forest University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Strength Training Group

Running Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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
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
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
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
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
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

Full Information

First Posted
June 17, 2016
Last Updated
May 8, 2020
Sponsor
Wake Forest University Health Sciences
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT03080246
Brief Title
Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners
Acronym
STARS
Official Title
Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overuse Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strength Training Group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Running Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strength Training Exercise
Primary Outcome Measure Information:
Title
Incidence of Overuse Injury (Physical Exam/Injury Report Form)
Description
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.
Time Frame
Month 18
Secondary Outcome Measure Information:
Title
Lower Extremity Muscular Strength (HUMAC norm isokinetic dynamometer)
Description
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.
Time Frame
Months 0, 9, and 18
Title
Biomechanical Joint Moments (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)
Description
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.
Time Frame
Month 0, 9, and 18
Title
Biomechanical Joint Forces (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)
Description
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.
Time Frame
Month 0, 9, and 18
Title
Biomechanical Joint Tissue Loading (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)
Description
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.
Time Frame
Month 0, 9, and 18
Title
Self-Efficacy (Adherence Self-Efficacy Questionnaire)
Description
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
Time Frame
Months 0, 9, and 18
Title
Quality of Life (SF-12 Health Related Quality of Life Survey)
Description
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
Time Frame
Months 0, 9, and 18
Title
Quality of Life (Satisfaction with Life Scale)
Description
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
Time Frame
Months 0, 9, and 18
Title
Quality of Life (Positive and Negative Affect Scale)
Description
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
Time Frame
Months 0, 9, and 18
Title
Quality of Life (State Trait Anxiety Inventory-S Scale)
Description
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
Time Frame
Months 0, 9, and 18
Title
Quality of Life (Visual Analog Pain Scale)
Description
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
Time Frame
Months 0, 9, and 18

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen P Messier, PhD
Organizational Affiliation
Wake Forest University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners

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