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Trial record 100 of 345 for:    sprains and strains

Alternate Run Study

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ClinicalTrials.gov Identifier: NCT03082651
Recruitment Status : Completed
First Posted : March 17, 2017
Last Update Posted : January 4, 2018
Sponsor:
Collaborator:
British Columbia Sports Medicine Research Foundation
Information provided by (Responsible Party):
Jack Taunton, University of British Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
Overuse Injury Other: Alternating run training load Other: Alternating footwear Other: Constant training Other: Constant footwear Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Investigating the Effect of Alternating Training Load and Footwear Singly or in Combination in Runners: The Alternate Run Study
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : December 1, 2017

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

Other: Constant footwear
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).
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

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

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.
Other: 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.

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

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).
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

Other: 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.




Primary Outcome Measures :
  1. Running injuries [ Time Frame: 13-weeks ]
    When an participant misses 3 consecutive assigned running workouts.


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082651


Locations
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Canada, British Columbia
Division of Sports Medicine
Vancouver, British Columbia, Canada, V6T 1Z3
Sponsors and Collaborators
University of British Columbia
British Columbia Sports Medicine Research Foundation

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Responsible Party: Jack Taunton, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03082651     History of Changes
Other Study ID Numbers: H16-00858
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jack Taunton, University of British Columbia:
Running injuries, footwear, alternating load

Additional relevant MeSH terms:
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Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries