Trial Outcomes & Findings for Peak Impact Forces and Metabolic Cost During Mid-Forefoot Striking in Shod Versus Barefoot Runners (NCT NCT01536171)

NCT ID: NCT01536171

Last Updated: 2014-04-21

Results Overview

This study will measure the metabolic rate when a person runs on the treadmill with shoes (shod) and without shoes. Each person will run for 20 minutes on the treadmill on two different days, one with and one day without shoes.

• Recruitment status: COMPLETED
• Target enrollment: 22 participants
• Primary outcome timeframe: Study consists of two visits, approximately 2 hours for each visit
• Results posted on: 2014-04-21

Participant Flow

Participant milestones

Measure	Mid-Forefoot Striking in Shod Versus Barefoot Runners trained runners (men,women) with a FM strike (verified in the lab)
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Mid-Forefoot Striking in Shod Versus Barefoot Runners trained runners (men,women) with a FM strike (verified in the lab)
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Peak Impact Forces and Metabolic Cost During Mid-Forefoot Striking in Shod Versus Barefoot Runners

Baseline characteristics by cohort

Measure	Mid-Forefoot Striking in Shod Versus Barefoot Runners n=22 Participants trained runners (men,women) with a FM strike (verified in the lab)
Age, Continuous	30 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Study consists of two visits, approximately 2 hours for each visit

This study will measure the metabolic rate when a person runs on the treadmill with shoes (shod) and without shoes.

Each person will run for 20 minutes on the treadmill on two different days, one with and one day without shoes.

Outcome measures

Measure	Mid-Forefoot Striking in Shod Versus Barefoot Runners n=22 Participants trained runners (men,women) with a FM strike (verified in the lab)
Metabolic Rate During Barefoot and Shod Running Metabolic rate shod running	57.8 kilojoules per minute Standard Deviation 7.8
Metabolic Rate During Barefoot and Shod Running Metabolic rate barefoot running	57.5 kilojoules per minute Standard Deviation 8.4

SECONDARY outcome

Timeframe: Study consists of two visits, approximately 2 hours for each visit

This study will be measuring the peak impact forces that a runner produces when running on the treadmill with shoes (shod) and without shoes.

Each person will run for 20 minutes on the treadmill on two different days, one with and one day without shoes.

Outcome measures

Measure	Mid-Forefoot Striking in Shod Versus Barefoot Runners n=22 Participants trained runners (men,women) with a FM strike (verified in the lab)
Peak Impact Forces During Barefoot and Shod Running Peak Impact forces during shod running	1756 Newtons Standard Deviation 310
Peak Impact Forces During Barefoot and Shod Running Peak impact during barefoot running	1703 Newtons Standard Deviation 285

Adverse Events

Mid-Forefoot Striking in Shod Versus Barefoot Runners

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mid-Forefoot Striking in Shod Versus Barefoot Runners n=22 participants at risk trained runners (men,women) with a FM strike (verified in the lab)
Skin and subcutaneous tissue disorders irritation to bottom of foot when running barefoot	4.5% 1/22 • Number of events 1 • 8 months

Additional Information

Dr. Heather K. Vincent, PhD

University of Florida

Phone: 352-273-7410

Email: vincehk@ortho.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place