- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03082651
Alternate Run Study
January 3, 2018 updated by: Jack Taunton, University of British Columbia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 1Z3
- Division of Sports Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Constant training/Constant footwear
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.
|
Runners will be assigned identical training sessions over a 7-day period.
Runners perform runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus).
|
EXPERIMENTAL: Alternate training/Constant footwear
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).
|
Runners perform runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus).
Runners will perform a variation of workouts, consisting of interval/speed work, tempo runs, and long-slow distance runs throughout each 7-day period
|
EXPERIMENTAL: Constant training/Alternating footwear
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.
|
Runners will be assigned identical training sessions over a 7-day period.
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.
|
EXPERIMENTAL: Alternating training/Alternating footwear
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).
|
Runners will perform a variation of workouts, consisting of interval/speed work, tempo runs, and long-slow distance runs throughout each 7-day period
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Running injuries
Time Frame: 13-weeks
|
When an participant misses 3 consecutive assigned running workouts.
|
13-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Running-related pain
Time Frame: 13-weeks
|
11-point numerical rating scale of overall pain associated with running
|
13-weeks
|
Region specific running-related pain
Time Frame: 13-weeks
|
Numerical rating scale for pain at selected anatomical locations: gluteal, low back, groin, thigh, hamstring, knee, calf, Achilles, ankle, foot.
|
13-weeks
|
Footwear comfort
Time Frame: 13-weeks
|
11-point rating of footwear comfort
|
13-weeks
|
Run Quality
Time Frame: 13-weeks
|
Study specific 11-point measure of how the footwear used affected each run's quality
|
13-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2016
Primary Completion (ACTUAL)
November 30, 2017
Study Completion (ACTUAL)
December 1, 2017
Study Registration Dates
First Submitted
March 13, 2017
First Submitted That Met QC Criteria
March 13, 2017
First Posted (ACTUAL)
March 17, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 4, 2018
Last Update Submitted That Met QC Criteria
January 3, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H16-00858
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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