NCT03080246

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

May 12, 2020

Status Verified

December 1, 2019

Enrollment Period

3.8 years

First QC Date

June 17, 2016

Last Update Submit

May 8, 2020

Conditions

Overuse Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Lower Extremity Muscular Strength (HUMAC norm isokinetic dynamometer)

    Months 0, 9, and 18

  • Biomechanical Joint Moments (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)

    Month 0, 9, and 18

  • Biomechanical Joint Forces (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)

    Month 0, 9, and 18

  • Biomechanical Joint Tissue Loading (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)

    Month 0, 9, and 18

  • Self-Efficacy (Adherence Self-Efficacy Questionnaire)

    Months 0, 9, and 18

  • +5 more secondary outcomes

Study Arms (2)

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).

Behavioral: Strength Training Exercise

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.

Interventions

Strength Training ExerciseBEHAVIORAL
Strength Training Group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

MeSH Terms

Conditions

Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and Injuries

Study Officials

  • Stephen P Messier, PhD

    Wake Forest University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

March 15, 2017

Study Start

December 1, 2015

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

May 12, 2020

Record last verified: 2019-12

Locations

US(1)