Alternate Run Study

Overuse Injury Clinical Trial

Official title:

Investigating the Effect of Alternating Training Load and Footwear Singly or in Combination in Runners: The Alternate Run Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082651
• Other study ID #: H16-00858
• Status: Completed
• Phase: N/A
• First received: March 13, 2017
• Last updated: January 3, 2018
• Start date: August 1, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: January 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 1, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cumulative Trauma Disorders
• Overuse Injury

Intervention

Other:
• Alternating run training load
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 footwear
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 training
Runners will be assigned identical training sessions over a 7-day period.
• Constant footwear
Runners perform runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus).

Locations

Country	Name	City	State
Canada	Division of Sports Medicine	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	British Columbia Sports Medicine Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Running injuries	When an participant misses 3 consecutive assigned running workouts.	13-weeks
Secondary	Running-related pain	11-point numerical rating scale of overall pain associated with running	13-weeks
Secondary	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.	13-weeks
Secondary	Footwear comfort	11-point rating of footwear comfort	13-weeks
Secondary	Run Quality	Study specific 11-point measure of how the footwear used affected each run's quality	13-weeks