Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners

NCT ID: NCT03080246

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-10-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Overuse Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Strength Training Exercise

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Strength Training Exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen P Messier, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University

Locations

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Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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W81XWH-16-1-0001

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00034222

Identifier Type: -

Identifier Source: org_study_id

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