Overuse InjurySTARSNCT03080246
Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners
A study testing Strength Training Exercise in people with Overuse Injury, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to look at the effect of strength training in preventing overuse injuries in female runners Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overuse Injury
- What is being tested?
- Strength Training Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
The purpose of this study is to look at the effect of strength training in preventing overuse injuries in female runners
Read the 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.
- Conditions
- Overuse Injury
- Being tested
- Strength Training Exercise
- Medical subject headings
- Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength Training ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 18
Secondary outcomes (10)
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.
Measured: Months 0, 9, and 18
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Months 0, 9, and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startDec 2015
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overuse InjuryStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Stephen P Messier, PhD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080246
- Sponsor's protocol ID
- IRB00034222
- Other IDs
- W81XWH-16-1-0001
- Acronym
- STARS
- Status last verified
- Dec 2019
- First submitted
- 17 Jun 2016
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners
- ClinicalTrials.gov ID
- NCT03080246
- Acronym / sponsor ID
- STARS / IRB00034222
- Conditions
- Overuse Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Dec 2015
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength Training Group | Active comparator | Behavioral: Strength Training ExerciseThis 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). |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength Training Exercise | Behavioural | Strength Training Group |
Primary outcome
Incidence of Overuse Injury (Physical Exam/Injury Report Form)
Time frame: Month 18
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.
10 secondary outcomes
Lower Extremity Muscular Strength (HUMAC norm isokinetic dynamometer)
Time frame: Months 0, 9, and 18
Biomechanical Joint Moments (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)
Time frame: Month 0, 9, and 18
Biomechanical Joint Forces (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)
Time frame: Month 0, 9, and 18
Biomechanical Joint Tissue Loading (3D kinematic and kinetic data collected by 6-camera motion capture gait analysis)
Time frame: Month 0, 9, and 18
Self-Efficacy (Adherence Self-Efficacy Questionnaire)
Time frame: Months 0, 9, and 18
Quality of Life (SF-12 Health Related Quality of Life Survey)
Time frame: Months 0, 9, and 18
Quality of Life (Satisfaction with Life Scale)
Time frame: Months 0, 9, and 18
Quality of Life (Positive and Negative Affect Scale)
Time frame: Months 0, 9, and 18
Quality of Life (State Trait Anxiety Inventory-S Scale)
Time frame: Months 0, 9, and 18
Quality of Life (Visual Analog Pain Scale)
Time frame: Months 0, 9, and 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Overuse Injury
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Cubital Tunnel Syndrome
Cubital Tunnel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen P Messier, PhD principal investigator
Wake Forest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength Training Exercise in people with Overuse Injury, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Overuse Injury (Physical Exam/Injury Report Form) (time frame: Month 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.