RunningNCT01900262
Exercise Interventions, Running Biomechanics and Injury in Novice Runners
A study testing Strengthening, Balance Training and Stretching in people with Running and Leg Injuries, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this study is to understand the effects of muscle strengthening and balance exercise interventions on muscle strength, running mechanics and postural control in novice recreational runners. Participants will be assessed before and after they engage in an 8-week exercise intervention program. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Running, Leg Injuries
- What is being tested?
- Strengthening, Balance Training and Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to May 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Novice recreational runners
- Less than one year of running experience
- Run at least twice a week for a total weekly distance between 5 and 15 km as your main form of physical activity
- 18-50 years of age
Who cannot join
- Neurological abnormalities or lower extremity injury or pain within three months of enrollment.
- No extensive history with balance training or isolated ankle strengthening within the last year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Isolated Strengthening and Functional Training on Strength, Running Mechanics, Postural Control and Injury Prevention in Novice Runners
The purpose of this study is to understand the effects of muscle strengthening and balance exercise interventions on muscle strength, running mechanics and postural control in novice recreational runners. Participants will be assessed before and after they engage in an 8-week exercise intervention program.
- Conditions
- Running, Leg Injuries
- Being tested
- Strengthening, Balance Training, Stretching
- Keywords
- Biomechanics, Ankle Strength, Postural Control, Running Mechanics
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrengtheningOther
Participants will be asked to complete 8 weeks of isolated ankle strengthening at home.
Balance TrainingOther
Participants will be asked to compete 8 weeks of functional balance training at home.
StretchingOther
Participants will be asked to complete a standard of practice static and dynamic stretching warm-up for 8 weeks at home.
| Study group | Role | What they receive |
|---|---|---|
| Strengthening | Experimental | Novice recreational runners from the Calgary area. Receives: Other: Strengthening |
| Balance Training | Experimental | Novice recreational runners from the Calgary area. Receives: Other: Balance Training |
| Stretching | Experimental | Novice recreational runners from the Calgary area. Receives: Other: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Strength
Strength of the muscles crossing the ankle, knee and hip joint will be assessed at baseline and after 8 weeks of training in order to assess the change in strength following training.
Measured: Week 0, Week 8
Change in Running Mechanics
Running kinematics and kinetics will be measured using 3D motion capture technology at baseline and after 8 weeks of training in order to assess the change in running mechanics following training.
Measured: Week 0, Week 8
Change in Postural Control
Postural control will be assessed using single leg stance and the star excursion balance test at baseline and after 8 weeks of training in order to assess the change in postural control following training.
Measured: Week 0, Week 8
Secondary outcomes (1)
Cumulative Running Related Injuries
Self-reported running-related injuries will be collected on a weekly basis for a total of 6 months following enrollment in order to quantify the cumulative amount of injuries.
Measured: Week 0 through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RunningStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Biomechanigg Research Ltd., Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jennifer Baltich, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900262
- Sponsor's protocol ID
- RRI2014
- Status last verified
- Aug 2015
- First submitted
- 8 Jul 2013
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Baltich J, Emery CA, Whittaker JL, Nigg BM. Running injuries in novice runners enrolled in different training interventions: a pilot randomized controlled trial. Scand J Med Sci Sports. 2017 Nov;27(11):1372-1383. doi: 10.1111/sms.12743. Epub 2016 Aug 3.
PubMed 27486011Baltich J, Emery CA, Stefanyshyn D, Nigg BM. The effects of isolated ankle strengthening and functional balance training on strength, running mechanics, postural control and injury prevention in novice runners: design of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Dec 4;15:407. doi: 10.1186/1471-2474-15-407.
PubMed 25471989
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Isolated Strengthening and Functional Training on Strength, Running Mechanics, Postural Control and Injury Prevention in Novice Runners
- ClinicalTrials.gov ID
- NCT01900262
- Acronym / sponsor ID
- RRI2014
- Conditions
- Running, Leg Injuries
- Keywords
- Biomechanics, Ankle Strength, Postural Control, Running Mechanics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Biomechanigg Research Ltd., Canadian Institutes of Health Research (CIHR)
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 16 Jul 2013 (estimated)
- 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 understand the effects of muscle strengthening and balance exercise interventions on muscle strength, running mechanics and postural control in novice recreational runners. Participants will be assessed before and after they engage in an 8-week exercise intervention program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strengthening | Experimental | Other: StrengtheningNovice recreational runners from the Calgary area. |
| Balance Training | Experimental | Other: Balance TrainingNovice recreational runners from the Calgary area. |
| Stretching | Experimental | Other: StretchingNovice recreational runners from the Calgary area. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Novice recreational runners
- Less than one year of running experience
- Run at least twice a week for a total weekly distance between 5 and 15 km as your main form of physical activity
- 18-50 years of age
Key exclusion criteria (2 listed)
- Neurological abnormalities or lower extremity injury or pain within three months of enrollment.
- No extensive history with balance training or isolated ankle strengthening within the last year.
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 |
|---|---|---|
| StrengtheningParticipants will be asked to complete 8 weeks of isolated ankle strengthening at home. | Other | Strengthening |
| Balance TrainingParticipants will be asked to compete 8 weeks of functional balance training at home. | Other | Balance Training |
| StretchingParticipants will be asked to complete a standard of practice static and dynamic stretching warm-up for 8 weeks at home. | Other | Stretching |
Primary outcome
Change in Strength
Time frame: Week 0, Week 8
Strength of the muscles crossing the ankle, knee and hip joint will be assessed at baseline and after 8 weeks of training in order to assess the change in strength following training.
Change in Running Mechanics
Time frame: Week 0, Week 8
Running kinematics and kinetics will be measured using 3D motion capture technology at baseline and after 8 weeks of training in order to assess the change in running mechanics following training.
Change in Postural Control
Time frame: Week 0, Week 8
Postural control will be assessed using single leg stance and the star excursion balance test at baseline and after 8 weeks of training in order to assess the change in postural control following training.
1 secondary outcome
Cumulative Running Related Injuries
Time frame: Week 0 through Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Derived from this study: PubMed 27486011Baltich J, Emery CA, Whittaker JL, Nigg BM. Running injuries in novice runners enrolled in different training interventions: a pilot randomized controlled trial. Scand J Med Sci Sports. 2017 Nov;27(11):1372-1383. doi: 10.1111/sms.12743. Epub 2016 Aug 3.
- Derived from this study: PubMed 25471989Baltich J, Emery CA, Stefanyshyn D, Nigg BM. The effects of isolated ankle strengthening and functional balance training on strength, running mechanics, postural control and injury prevention in novice runners: design of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Dec 4;15:407. doi: 10.1186/1471-2474-15-407.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening, Balance Training and Stretching in people with Running and Leg Injuries, run by University of Calgary at 1 site in Canada.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Aug 2015. 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 Canada. 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?
Results are not available in the source record.
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?
Change in Strength (time frame: Week 0, Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01900262, which also lists 2 linked publications.
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 17 Aug 2015.