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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03080246
Other study ID # IRB00034222
Secondary ID W81XWH-16-1-0001
Status Completed
Phase N/A
First received
Last updated
Start date December 2015
Est. completion date October 2019

Study information

Verified date December 2019
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date October 2019
Est. primary completion date October 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Behavioral:
Strength Training Exercise


Locations

Country Name City State
United States Wake Forest University Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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