Gait Disorder, SensorimotorNCT03057522
Step Rate in Recreational Runners
A study testing Change in running cadence in people with Gait Disorder, Sensorimotor, run by Mayo Clinic at 1 site in United States.
Trial summary
This will be a pilot study to determine if a 6 week home training program can increase preferred step rate (cadence) in recreational runners. Increase in step rate has been correlated with decreased stress at lower limb joints in runners. This has the potential of decreasing overuse injuries in this population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gait Disorder, Sensorimotor
- What is being tested?
- Change in running cadence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 1 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male or female runners
- 18 years of age or greater
- run two or more times per week most weeks of the year for at least 4 years
- cadence of 85 strides/min or less as determined at initial evaluation
- no musculoskeletal injuries or illnesses that would limit running in the last 6 months
- currently running at least 15 miles a week
Who cannot join
- baseline running cadence greater than 85 strides/min
- inability to run
- cardiovascular disease
- greater than 2 cardiovascular risk factors
- peripheral vascular disease
- neurological disease
- musculoskeletal injury or disease that causes pain with running
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Effect of a Home Training Program on Preferred Step Rate in Recreational Runners
This will be a pilot study to determine if a 6 week home training program can increase preferred step rate (cadence) in recreational runners. Increase in step rate has been correlated with decreased stress at lower limb joints in runners. This has the potential of decreasing overuse injuries in this population.
Research participants will have their preferred cadence evaluated at the beginning of the study. The athletes will be randomly assigned to two groups. One group will continue to train without intervention and the other group will train at a cadence of 10% higher than their preferred step rate.
Read more
At the end of 6 weeks the participants will have their preferred cadence reevaluated using the same method as pre-participation cadence was determined.
The investigators hypothesis the preferred running cadence of recreational runners following the intervention will be 5-10% greater than prior to the intervention and the increased cadence will be maintained for 6 months following the intervention.
- Conditions
- Gait Disorder, Sensorimotor
- Being tested
- Change in running cadence
- Keywords
- Run, Cadence, Home exercise
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in running cadenceBehavioural
The intervention will involve a home exercise program designed to increase the running cadence in recreational runners.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group will undergo home exercise program designed to increase their running cadence. Receives: Behavioral: Change in running cadence |
| Control Group | No intervention | This group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Running cadence
Running cadence (steps per minute) will be evaluated using a running cadence sensor to determine if the intervention subjects increased their running cadence by 10 steps per minute following the intervention.
Measured: 6 weeks
Running cadence
Running cadence (steps per minute) will be evaluated using a running cadence sensor to determine if the intervention subjects maintained their increased running cadence for 6 months following the intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start1 Feb 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorder, SensorimotorStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled study evaluating whether a home exercise program can increase the running cadence of recreational runners.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan T. Finnoff, Mayo Clinic
- Investigators
- Jonathan T Finnoff, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057522
- Sponsor's protocol ID
- 16-008532
- Status last verified
- Nov 2018
- First submitted
- 14 Feb 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Home Training Program on Preferred Step Rate in Recreational Runners
- ClinicalTrials.gov ID
- NCT03057522
- Acronym / sponsor ID
- 16-008532
- Conditions
- Gait Disorder, Sensorimotor
- Keywords
- Run, Cadence, Home exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 20 Feb 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.
This will be a pilot study to determine if a 6 week home training program can increase preferred step rate (cadence) in recreational runners. Increase in step rate has been correlated with decreased stress at lower limb joints in runners. This has the potential of decreasing overuse injuries in this population.
Research participants will have their preferred cadence evaluated at the beginning of the study. The athletes will be randomly assigned to two groups. One group will continue to train without intervention and the other group will train at a cadence of 10% higher than their preferred step rate.
At the end of 6 weeks the participants will have their preferred cadence reevaluated using the same method as pre-participation cadence was determined.
The investigators hypothesis the preferred running cadence of recreational runners following the intervention will be 5-10% greater than prior to the intervention and the increased cadence will be maintained for 6 months following the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled study evaluating whether a home exercise program can increase the running cadence of recreational runners.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Change in running cadenceThis group will undergo home exercise program designed to increase their running cadence. |
| Control Group | No intervention | –This group will not receive any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- healthy male or female runners
- 18 years of age or greater
- run two or more times per week most weeks of the year for at least 4 years
- cadence of 85 strides/min or less as determined at initial evaluation
- no musculoskeletal injuries or illnesses that would limit running in the last 6 months
Key exclusion criteria (7 listed)
- baseline running cadence greater than 85 strides/min
- inability to run
- cardiovascular disease
- greater than 2 cardiovascular risk factors
- peripheral vascular disease
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 |
|---|---|---|
| Change in running cadenceThe intervention will involve a home exercise program designed to increase the running cadence in recreational runners. | Behavioural | Intervention Group |
Primary outcome
Running cadence
Time frame: 6 weeks
Running cadence (steps per minute) will be evaluated using a running cadence sensor to determine if the intervention subjects increased their running cadence by 10 steps per minute following the intervention.
Running cadence
Time frame: 6 months
Running cadence (steps per minute) will be evaluated using a running cadence sensor to determine if the intervention subjects maintained their increased running cadence for 6 months following the intervention.
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 14 Nov 2018.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers
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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.
Jonathan T Finnoff principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change in running cadence in people with Gait Disorder, Sensorimotor, run by Mayo Clinic 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 6 inclusion and 7 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 14 Nov 2018. 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 cadence (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 14 Nov 2018.