Trial Outcomes & Findings for Running Retraining to Minimize Braking Forces (NCT NCT03302975)

NCT ID: NCT03302975

Last Updated: 2020-01-18

Results Overview

The peak horizontal force applied in the posterior direction during the stance phase of running

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: 15 weeks
• Results posted on: 2020-01-18

Participant Flow

Participant milestones

Measure	Real Time Biofeedback Real-time visual biofeedback of braking forces during a treadmill run. Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running
Overall Study STARTED	16
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Real Time Biofeedback Real-time visual biofeedback of braking forces during a treadmill run. Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running
Overall Study Lost to Follow-up	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Real Time Biofeedback n=12 Participants Real-time visual biofeedback of braking forces during a treadmill run. Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants
Age, Continuous	39.2 years STANDARD_DEVIATION 8.7 • n=12 Participants
Sex: Female, Male Female	12 Participants n=12 Participants
Sex: Female, Male Male	0 Participants n=12 Participants
Region of Enrollment Canada	12 participants n=12 Participants
Peak Braking Force	0.28 Body Weight STANDARD_DEVIATION 0.04 • n=12 Participants
Step Length	0.91 m STANDARD_DEVIATION 0.07 • n=12 Participants

PRIMARY outcome

Timeframe: 15 weeks

The peak horizontal force applied in the posterior direction during the stance phase of running

Outcome measures

Measure	Real Time Biofeedback n=12 Participants Real-time visual biofeedback of braking forces during a treadmill run. Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running
Peak Braking Force	0.24 Body Weight Standard Deviation 0.02

SECONDARY outcome

Timeframe: 15 weeks

The average vertical loading rate during stance phase

Outcome measures

Measure	Real Time Biofeedback n=12 Participants Real-time visual biofeedback of braking forces during a treadmill run. Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running
Average Vertical Loading Rate	36.05 Body Weight/second Standard Deviation 7.5

SECONDARY outcome

Timeframe: 15 weeks

The average step length

Outcome measures

Measure	Real Time Biofeedback n=12 Participants Real-time visual biofeedback of braking forces during a treadmill run. Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running
Step Length	0.85 m Standard Deviation 0.05

Adverse Events

Real Time Biofeedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chris Napier

Univeristy of British Columbia

Phone: 604-721-1310

Email: chris.napier@ubc.ca

Results disclosure agreements

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