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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-16-1-0001 | Other Identifier | Army Med R & D Command |
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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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The purpose of this study is to look at the effect of strength training in preventing overuse injuries in female runners
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strength Training Group | Active Comparator | 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). |
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| Running Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strength Training Exercise | Behavioral |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen P Messier, PhD | Wake Forest University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University | Winston-Salem | North Carolina | 27109 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 11, 2018 | May 8, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012090 | Cumulative Trauma Disorders |
| ID | Term |
|---|---|
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
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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 |