search
Back to results

Alternate Run Study

Primary Purpose

Overuse Injury

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Alternating run training load
Alternating footwear
Constant training
Constant footwear
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overuse Injury focused on measuring Running injuries, footwear, alternating load

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Division of Sports Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Constant training/Constant footwear

Alternate training/Constant footwear

Constant training/Alternating footwear

Alternating training/Alternating footwear

Arm Description

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.

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).

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.

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).

Outcomes

Primary Outcome Measures

Running injuries
When an participant misses 3 consecutive assigned running workouts.

Secondary Outcome Measures

Running-related pain
11-point numerical rating scale of overall pain associated with running
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.
Footwear comfort
11-point rating of footwear comfort
Run Quality
Study specific 11-point measure of how the footwear used affected each run's quality

Full Information

First Posted
March 13, 2017
Last Updated
January 3, 2018
Sponsor
University of British Columbia
Collaborators
British Columbia Sports Medicine Research Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT03082651
Brief Title
Alternate Run Study
Official Title
Investigating the Effect of Alternating Training Load and Footwear Singly or in Combination in Runners: The Alternate Run Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
British Columbia Sports Medicine Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overuse Injury
Keywords
Running injuries, footwear, alternating load

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Constant training/Constant footwear
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Alternate training/Constant footwear
Arm Type
Experimental
Arm Description
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).
Arm Title
Constant training/Alternating footwear
Arm Type
Experimental
Arm Description
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.
Arm Title
Alternating training/Alternating footwear
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Alternating run training load
Intervention Description
Runners will perform a variation of workouts, consisting of interval/speed work, tempo runs, and long-slow distance runs throughout each 7-day period
Intervention Type
Other
Intervention Name(s)
Alternating footwear
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Constant training
Intervention Description
Runners will be assigned identical training sessions over a 7-day period.
Intervention Type
Other
Intervention Name(s)
Constant footwear
Intervention Description
Runners perform runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus).
Primary Outcome Measure Information:
Title
Running injuries
Description
When an participant misses 3 consecutive assigned running workouts.
Time Frame
13-weeks
Secondary Outcome Measure Information:
Title
Running-related pain
Description
11-point numerical rating scale of overall pain associated with running
Time Frame
13-weeks
Title
Region specific running-related pain
Description
Numerical rating scale for pain at selected anatomical locations: gluteal, low back, groin, thigh, hamstring, knee, calf, Achilles, ankle, foot.
Time Frame
13-weeks
Title
Footwear comfort
Description
11-point rating of footwear comfort
Time Frame
13-weeks
Title
Run Quality
Description
Study specific 11-point measure of how the footwear used affected each run's quality
Time Frame
13-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Division of Sports Medicine
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Alternate Run Study

We'll reach out to this number within 24 hrs