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Completed

NCT Number: NCT03082651

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.

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Key information

Conditions

Overuse Injury Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Sports Medicine

Vancouver, British Columbia, V6T 1Z3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alternating run training load

Other

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

Other

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

Other

Runners will be assigned identical training sessions over a 7-day period.

Constant footwear

Other

Runners perform runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus).

Primary outcomes

  1. Running injuries

    Time frame: 13-weeks

    When an participant misses 3 consecutive assigned running workouts.

Secondary outcomes

  1. Running-related pain

    Time frame: 13-weeks

    11-point numerical rating scale of overall pain associated with running

  2. 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.

  3. Footwear comfort

    Time frame: 13-weeks

    11-point rating of footwear comfort

  4. Run Quality

    Time frame: 13-weeks

    Study specific 11-point measure of how the footwear used affected each run's quality

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • British Columbia Sports Medicine Research Foundation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2017
Registry last updated
Jan 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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