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

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.

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

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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