A Comparative Effectiveness Study of Two Interventions Aimed at Reducing Impact Loads in Runners

NCT02987517 | Completed

• 1 other identifier: 2015P000724
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will use a comparative effectiveness design of two interventions known to reduce running impacts. The study will be conducted at the Spaulding National Running Center. A total of 40 male and female participants, between ages 18-50 years, running 10- 30 miles per week will be recruited from the local running community. All potential subjects will be cleared for physical activity using a Physical Activity Readiness Questionnaire (PAR-Q) and screened via high-speed video to determine their habitual footstrike pattern. Those who are rearfoot strikers will be included and will then be randomized to either an increased cadence (CAD) or a forefoot strike (FFS) intervention group. Standardized running shoes will be provided to both groups for the duration of the study. All participants will attend 2 strength-training instruction sessions with a physical therapist prior to gait-retraining intervention. They will be instructed to perform the learned exercises daily for 4 weeks to prepare the body tissues for forces associated with new gait methods. Subjects will then attend 8 gait-retraining sessions over 2-3 weeks. Sessions will be scheduled as two sequential days of training followed by a day of rest. The gait retraining protocols will be conducted on a treadmill. 3D Motion Capture analysis will be conducted at baseline and at 3 points following intervention (1 week, 1 month, and 6 months).

Conditions

Musculoskeletal Injury

Keywords

running; vertical load rates; cadence; footstrike

Outcome Measures

Primary Outcomes (3)

• Change in Vertical Load Rates

  average rate of loading calculated from Vertical Ground Reaction Force

  baseline, 1 week follow up, 1 month follow up, 6 month follow up

• Change in Foot Angle

  angle of foot in relation to ground, determines foot strike type

  baseline, 1 week follow up, 1 month follow up, 6 month follow up

• Change in running cadence (steps per minute)

  number of steps taken per minute

  baseline, 1 week follow up, 1 month follow up, 6 month follow up

Study Arms (2)

Cadence

EXPERIMENTAL

Runners who use an increased running cadence of 7.5 percent over preferred running cadence.

Other: Increased running cadence gait retraining; Other: Strengthening exercises

Forefoot Strike

EXPERIMENTAL

Runners who use a forefoot strike instead of a rear foot strike

Other: Forefoot Strike gait retraining; Other: Strengthening exercises

Interventions

Increased running cadence gait retraining OTHER

Runners use an increased cadence, or step rate, 7.5% greater than baseline preferred cadence

Cadence

Forefoot Strike gait retraining OTHER

Runners use a forefoot strike running gait instead of a rear foot strike running gait.

Forefoot Strike

Strengthening exercises OTHER

foot and ankle strengthening exercises performed by all subjects to prepare musculoskeletal tissues for requirements of new running gait.

Cadence; Forefoot Strike

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• history of running-related injury (outside of the past 3 months)
• ages 18 to 50 years
• currently running 5 to15 miles per week for at least 3 months
• habitual running cadence of less than or equal to 170 steps/min
• no contraindications for exercise as determined by the Physical Activity Readiness Questionnaire (PAR-Q).

You may not qualify if:

• do not use a heel strike as their habitual gait pattern
• habitual cadence greater than 170 steps/min
• history of injury within the past 3 months
• any history of stress fracture to any bone of the foot or ankle
• any past injuries or surgeries that have permanently altered gait
• color blindness
• Injury will be defined as:
• Running-related (training or competition) musculoskeletal pain in the lower limbs that causes a restriction on or stoppage of running (distance, speed, duration or training) for at least seven days or three consecutive scheduled training sessions, or that requires the runner to consult a physician or other health professional

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Officials

• Irene Davis, PhD

  Director, Spaulding National Running Center

  STUDY DIRECTOR

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: Director, Spaulding National Running Center

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 9, 2016
• Study Start: January 1, 2016
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: April 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share