InjuriesNCT03293121
Effect of Strength and Coordination Training on Biomechanics and Injury in New Runners
A study testing Strength and Coordination Training and Walking in people with Injuries and Patellofemoral Pain Syndrome, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The investigators hypothesize that new runners participating in an 8 week strength and coordination training program prior to beginning to run will 1) display different coordination patterns , and 2) experience fewer injuries, compared to new runners who do not perform strength or coordination training prior to… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Injuries, Patellofemoral Pain Syndrome, Iliotibial Band Syndrome
- What is being tested?
- Strength and Coordination Training and Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2017to 4 Jun 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No previous participation in running races
- Run less than 10km total in past year
- Able to run continuously (ie at least 5mph) for 5 min (so that biomechanical analysis of running form can be conducted)
- Female participants may not be pregnant
- Participants will be screened using the PARQ+ form, and Parmed-X form completed by a physician if necessary
- Cleared for physical activity through screening
- English-speaking
Who cannot join
- Previous (at any time of life) training of 3 or months of consistently running 3 or more days per week
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The investigators hypothesize that new runners participating in an 8 week strength and coordination training program prior to beginning to run will 1) display different coordination patterns , and 2) experience fewer injuries, compared to new runners who do not perform strength or coordination training prior to running.
Read the detailed description
The study will investigate the effect of a sequenced training program - beginning with strength training, followed by running-specific coordination exercises, and finally a gradual introduction to running - on strength, coordination and injury incidence in a group of novice runners. he investigators hypothesize that runners who perform strength and coordination training prior to beginning to run will 1) demonstrate greater lower extremity strength, 2) demonstrate alters coordination patterns and 3) experience fewer injuries, when compared to a control group of novice runners who perform no physical preparation prior to a gradual introduction to running. The possible long-term benefits of this study include reduced burden of running-related injuries, increased participation in the sport of running, improved cardiovascular and metabolic health characteristics, and reduced incidence of disease such as cardiovascular events and cancer.
- Being tested
- Strength and Coordination Training, Walking
- Keywords
- running related injuries
- Medical subject headings
- Wounds and Injuries, Patellofemoral Pain Syndrome, Iliotibial Band Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength and Coordination TrainingBehavioural
Perform training exercises 3/week. Weeks 1-2: general strength (isolated muscle groups) Weeks 3-4: running-specific strength (multi-joint, upright) Weeks 5-6: power/coordination I (low amplitude/intensity) Weeks 7-8: power/coordination II (higher amplitude/intensity) Weeks 9-16: Run training. Each training session will start with a 10 minute strength \& coordination warm up. Group will gradually progress from mixed run/walk for 20 minutes to a 40 minute run.
WalkingBehavioural
Perform training exercises 3/week. Weeks 1-2: 30 minute walk Weeks 3-4: 35 minute walk Weeks 5-6: 40 minute walk Weeks 7-8: 45 minute walk Weeks 9-16: Run training. Each training session will start with a 10 minute walking warm up. Group will gradually progress from mixed run/walk for 20 minutes to a 40 minute run.
| Study group | Role | What they receive |
|---|---|---|
| Strength and Coordination Training | Experimental | The strength and coordination group will perform a progression of exercises utilizing body weight and resistance bands as resistance. Exercises include squats, lunges, jumps etc. typical of a normal strength training program. Receives: Behavioral: Strength and Coordination Training |
| Walking | Active comparator | The walking group will be instructed to walk 3x/week, progressing from 30 to 45 min over 8 weeks. Receives: Behavioral: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Running biomechanics
Relative joint motions will be assessed continuously throughout the stride cycle using a vector coding technique.
Measured: Change from week 0 to week 16
Secondary outcomes (1)
Running injury.
Time to first running related injury.
Measured: Measured in days over the 16 week training period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start15 Jan 2017
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuriesStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheryl Finucane, PT, PhD, CEEAA, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293121
- Sponsor's protocol ID
- HM20010685
- Status last verified
- Jun 2019
- First submitted
- 15 Sep 2017
- Last updated
- 18 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strength and Coordination Training on Biomechanics and Injury in New Runners
- ClinicalTrials.gov ID
- NCT03293121
- Acronym / sponsor ID
- HM20010685
- Keywords
- running related injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 26 Sep 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 investigators hypothesize that new runners participating in an 8 week strength and coordination training program prior to beginning to run will 1) display different coordination patterns , and 2) experience fewer injuries, compared to new runners who do not perform strength or coordination training prior to running.
Detailed description
The study will investigate the effect of a sequenced training program - beginning with strength training, followed by running-specific coordination exercises, and finally a gradual introduction to running - on strength, coordination and injury incidence in a group of novice runners. he investigators hypothesize that runners who perform strength and coordination training prior to beginning to run will 1) demonstrate greater lower extremity strength, 2) demonstrate alters coordination patterns and 3) experience fewer injuries, when compared to a control group of novice runners who perform no physical preparation prior to a gradual introduction to running. The possible long-term benefits of this study include reduced burden of running-related injuries, increased participation in the sport of running, improved cardiovascular and metabolic health characteristics, and reduced incidence of disease such as cardiovascular events and cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength and Coordination Training | Experimental | Behavioral: Strength and Coordination TrainingThe strength and coordination group will perform a progression of exercises utilizing body weight and resistance bands as resistance. Exercises include squats, lunges, jumps etc. typical of a normal strength training program. |
| Walking | Active comparator | Behavioral: WalkingThe walking group will be instructed to walk 3x/week, progressing from 30 to 45 min over 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- No previous participation in running races
- Run less than 10km total in past year
- Able to run continuously (ie at least 5mph) for 5 min (so that biomechanical analysis of running form can be conducted)
- Female participants may not be pregnant
- Participants will be screened using the PARQ+ form, and Parmed-X form completed by a physician if necessary
Key exclusion criteria (1 listed)
- Previous (at any time of life) training of 3 or months of consistently running 3 or more days per week
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 and Coordination TrainingPerform training exercises 3/week. Weeks 1-2: general strength (isolated muscle groups) Weeks 3-4: running-specific strength (multi-joint, upright) Weeks 5-6: power/coordination I (low amplitude/intensity) Weeks 7-8: power/coordination II (higher amplitude/intensity) Weeks 9-16: Run training. Each training session will start with a 10 minute strength \& coordination warm up. Group will gradually progress from mixed run/walk for 20 minutes to a 40 minute run. | Behavioural | Strength and Coordination Training |
| WalkingPerform training exercises 3/week. Weeks 1-2: 30 minute walk Weeks 3-4: 35 minute walk Weeks 5-6: 40 minute walk Weeks 7-8: 45 minute walk Weeks 9-16: Run training. Each training session will start with a 10 minute walking warm up. Group will gradually progress from mixed run/walk for 20 minutes to a 40 minute run. | Behavioural | Walking |
Primary outcome
Running biomechanics
Time frame: Change from week 0 to week 16
Relative joint motions will be assessed continuously throughout the stride cycle using a vector coding technique.
1 secondary outcome
Running injury.
Time frame: Measured in days over the 16 week training period.
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 18 Jun 2019.
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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.
Sheryl Finucane, PT, PhD, CEEAA principal investigator
Virginia Commonwealth 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 and Coordination Training and Walking in people with Injuries and Patellofemoral Pain Syndrome, run by Virginia Commonwealth University 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 7 inclusion and 1 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 18 Jun 2019. 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?
Running biomechanics (time frame: Change from week 0 to week 16). 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 18 Jun 2019.