NCT03082651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 4, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

March 13, 2017

Last Update Submit

January 3, 2018

Conditions

Keywords

Running injuries, footwear, alternating load

Outcome Measures

Primary Outcomes (1)

  • Running injuries

    When an participant misses 3 consecutive assigned running workouts.

    13-weeks

Secondary Outcomes (4)

  • Running-related pain

    13-weeks

  • Region specific running-related pain

    13-weeks

  • Footwear comfort

    13-weeks

  • Run Quality

    13-weeks

Study Arms (4)

Constant training/Constant footwear

ACTIVE COMPARATOR

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 trainingOther: Constant footwear

Alternate training/Constant footwear

EXPERIMENTAL

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 loadOther: Constant footwear

Constant training/Alternating footwear

EXPERIMENTAL

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 footwearOther: Constant training

Alternating training/Alternating footwear

EXPERIMENTAL

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 loadOther: Alternating footwear

Interventions

Runners will perform a variation of workouts, consisting of interval/speed work, tempo runs, and long-slow distance runs throughout each 7-day period

Alternate training/Constant footwearAlternating training/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.

Alternating training/Alternating footwearConstant training/Alternating footwear

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

Constant training/Alternating footwearConstant training/Constant footwear

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

Alternate training/Constant footwearConstant training/Constant footwear

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Sports Medicine

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2017

First Posted

March 17, 2017

Study Start

August 1, 2016

Primary Completion

November 30, 2017

Study Completion

December 1, 2017

Last Updated

January 4, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations