Overuse InjuryNCT03082651
Alternate Run Study
A study testing Alternating run training load, Alternating footwear and Constant training in people with Overuse Injury, run by University of British Columbia at 1 site in Canada.
Trial summary
The proposed study will investigate the effect of alternating footwear model and workout-type on the occurrence of running-related pain. To achieve this goal participants will be randomly assigned into one of four different groups who will perform: 1) the same workout throughout a week in the same running shoe model… Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overuse Injury
- What is being tested?
- Alternating run training load, Alternating footwear and Constant training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2016to 1 Dec 2017
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects in this study will include adults (men and women) between the ages of 19 and 60, have been running on a regular basis (minimum once per week) over the past 6 months, are able to run for 60 minutes continuously, could tolerate 20-40km per week in training, and have not experienced a running related injury requiring a stoppage of 2-weeks or more in the past 6 months. Only neutral and pronated foot postures (Foot Posture Index between -2 and 8) will be recruited
Who cannot join
- have a history of surgery to their plantar fascia or Achilles tendon,
- have a diagnosis of osteoarthritis - or other degenerative musculoskeletal disorder - affecting the lower extremity,
- take analgesic or anti-inflammatory medication 2 or more times per week over the past 4 weeks,
- take part in high impact activities 2 or more times per week during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effect of Alternating Training Load and Footwear Singly or in Combination in Runners: The Alternate Run Study
The proposed study will investigate the effect of alternating footwear model and workout-type on the occurrence of running-related pain. To achieve this goal participants will be randomly assigned into one of four different groups who will perform: 1) the same workout throughout a week in the same running shoe model, 2) alternating workout-types throughout the week in the same shoe model, 3) the same workout throughout a week in alternating shoe models, and 4) alternating workouts in alternating shoes. Participants will be characterized based on body alignment, strength, injury and training history. Pain and injury status will be monitored.
- Conditions
- Overuse Injury
- Being tested
- Alternating run training load, Alternating footwear, Constant training, Constant footwear
- Keywords
- Running injuries, footwear, alternating load
- 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.
Alternating run training loadOther
Runners will perform a variation of workouts, consisting of interval/speed work, tempo runs, and long-slow distance runs throughout each 7-day period
Alternating footwearOther
Runners will be assigned identical training sessions over a 7-day period but will alternate use of two different models of running shoes across successive workouts (Nike Pegasus and Nike Zoom Streak). The Zoom Streak has 10mm less midsole material, a less supportive heel counter and more flexible forefoot providing a more responsive feel to the runner.
Constant trainingOther
Runners will be assigned identical training sessions over a 7-day period.
Constant footwearOther
Runners perform runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus).
| Study group | Role | What they receive |
|---|---|---|
| Constant training/Constant footwear | Active comparator | Group 1 - Runners will be assigned identical training sessions over a 7-day period and will perform these runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus). The weekly training volume will increase on a weekly basis in order to progressively increase training load in preparation for the half-marathon event. Receives: Other: Constant training; Other: Constant footwear |
| Alternate training/Constant footwear | Experimental | Group 2 - Runners will perform a variation of workouts, consisting of interval/speed work, tempo runs, and long-slow distance runs throughout each 7-day period. As with Group 1, weekly training volume will increase on a weekly basis. Runners in Group 2 will perform these runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus). Receives: Other: Alternating run training load; Other: Constant footwear |
| Constant training/Alternating footwear | Experimental | Group 3 - Runners will be assigned identical training sessions over a 7-day period but will alternate use of two different models of running shoes across successive workouts (Nike Pegasus and Nike Zoom Streak). The Zoom Streak has 10mm less midsole material, a less supportive heel counter and more flexible forefoot providing a more responsive feel to the runner. Receives: Other: Alternating footwear; Other: Constant training |
| Alternating training/Alternating footwear | Experimental | Group 4 - Runners will be assigned a variation of workouts throughout each 7-day period and will alternate use of two different models of running shoes across successive workouts (Nike Pegasus and Nike Zoom Streak). Receives: Other: Alternating run training load; Other: Alternating footwear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Running injuries
When an participant misses 3 consecutive assigned running workouts.
Measured: 13-weeks
Secondary outcomes (4)
Running-related pain
11-point numerical rating scale of overall pain associated with running
Measured: 13-weeks
Region specific running-related pain
Numerical rating scale for pain at selected anatomical locations: gluteal, low back, groin, thigh, hamstring, knee, calf, Achilles, ankle, foot.
Measured: 13-weeks
Footwear comfort
11-point rating of footwear comfort
Measured: 13-weeks
Run Quality
Study specific 11-point measure of how the footwear used affected each run's quality
Measured: 13-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Aug 2016
- Primary completion30 Nov 2017
- Study completion1 Dec 2017
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 University of British ColumbiaThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- British Columbia Sports Medicine Research Foundation
- Responsible party
- Principal investigator, Jack Taunton, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082651
- Sponsor's protocol ID
- H16-00858
- Status last verified
- Jan 2018
- First submitted
- 13 Mar 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Alternating Training Load and Footwear Singly or in Combination in Runners: The Alternate Run Study
- ClinicalTrials.gov ID
- NCT03082651
- Acronym / sponsor ID
- H16-00858
- Conditions
- Overuse Injury
- Keywords
- Running injuries, footwear, alternating load
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- British Columbia Sports Medicine Research Foundation
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 17 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 proposed study will investigate the effect of alternating footwear model and workout-type on the occurrence of running-related pain. To achieve this goal participants will be randomly assigned into one of four different groups who will perform: 1) the same workout throughout a week in the same running shoe model, 2) alternating workout-types throughout the week in the same shoe model, 3) the same workout throughout a week in alternating shoe models, and 4) alternating workouts in alternating shoes. Participants will be characterized based on body alignment, strength, injury and training history. Pain and injury status will be monitored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Constant training/Constant footwear | Active comparator | Other: Constant training, Other: Constant footwearGroup 1 - Runners will be assigned identical training sessions over a 7-day period and will perform these runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus). The weekly training volume will increase on a weekly basis in order to progressively increase training load in preparation for the half-marathon event. |
| Alternate training/Constant footwear | Experimental | Other: Alternating run training load, Other: Constant footwearGroup 2 - Runners will perform a variation of workouts, consisting of interval/speed work, tempo runs, and long-slow distance runs throughout each 7-day period. As with Group 1, weekly training volume will increase on a weekly basis. Runners in Group 2 will perform these runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus). |
| Constant training/Alternating footwear | Experimental | Other: Alternating footwear, Other: Constant trainingGroup 3 - Runners will be assigned identical training sessions over a 7-day period but will alternate use of two different models of running shoes across successive workouts (Nike Pegasus and Nike Zoom Streak). The Zoom Streak has 10mm less midsole material, a less supportive heel counter and more flexible forefoot providing a more responsive feel to the runner. |
| Alternating training/Alternating footwear | Experimental | Other: Alternating run training load, Other: Alternating footwearGroup 4 - Runners will be assigned a variation of workouts throughout each 7-day period and will alternate use of two different models of running shoes across successive workouts (Nike Pegasus and Nike Zoom Streak). |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects in this study will include adults (men and women) between the ages of 19 and 60, have been running on a regular basis (minimum once per week) over the past 6 months, are able to run for 60 minutes continuously, could tolerate 20-40km per week in training, and have not experienced a running related injury requiring a stoppage of 2-weeks or more in the past 6 months. Only neutral and pronated foot postures (Foot Posture Index between -2 and 8) will be recruited
Key exclusion criteria (4 listed)
- have a history of surgery to their plantar fascia or Achilles tendon,
- have a diagnosis of osteoarthritis - or other degenerative musculoskeletal disorder - affecting the lower extremity,
- take analgesic or anti-inflammatory medication 2 or more times per week over the past 4 weeks,
- take part in high impact activities 2 or more times per week during the study period
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 |
|---|---|---|
| Alternating run training loadRunners will perform a variation of workouts, consisting of interval/speed work, tempo runs, and long-slow distance runs throughout each 7-day period | Other | Alternate training/Constant footwear, Alternating training/Alternating footwear |
| Alternating footwearRunners will be assigned identical training sessions over a 7-day period but will alternate use of two different models of running shoes across successive workouts (Nike Pegasus and Nike Zoom Streak). The Zoom Streak has 10mm less midsole material, a less supportive heel counter and more flexible forefoot providing a more responsive feel to the runner. | Other | Alternating training/Alternating footwear, Constant training/Alternating footwear |
| Constant trainingRunners will be assigned identical training sessions over a 7-day period. | Other | Constant training/Alternating footwear, Constant training/Constant footwear |
| Constant footwearRunners perform runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus). | Other | Alternate training/Constant footwear, Constant training/Constant footwear |
Primary outcome
Running injuries
Time frame: 13-weeks
When an participant misses 3 consecutive assigned running workouts.
4 secondary outcomes
Running-related pain
Time frame: 13-weeks
Region specific running-related pain
Time frame: 13-weeks
Footwear comfort
Time frame: 13-weeks
Run Quality
Time frame: 13-weeks
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 4 Jan 2018.
- Individual participant dataSharing planned: No
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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 Alternating run training load, Alternating footwear and Constant training in people with Overuse Injury, run by University of British Columbia 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 1 inclusion and 4 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 4 Jan 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 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?
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 injuries (time frame: 13-weeks). 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 4 Jan 2018.