Trial Outcomes & Findings for Muscle Property, Alignment and Joint Loading in People With Knee Osteoarthritis (NCT NCT03628508)

NCT ID: NCT03628508

Last Updated: 2021-09-16

Results Overview

External knee moment in the frontal plane during early stance phase of walking

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: At baseline and one week after intervention
• Results posted on: 2021-09-16

Participant Flow

Participant milestones

Measure	Exercise Six-week exercise including stretching, strengthening, endurance and gait modification Exercise: Comprehensive exercise program including strengthening, stretching, gait modification etc.
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Exercise Six-week exercise including stretching, strengthening, endurance and gait modification Exercise: Comprehensive exercise program including strengthening, stretching, gait modification etc.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Exercise n=40 Participants Six-week exercise including stretching, strengthening, endurance and gait modification Exercise: Comprehensive exercise program including strengthening, stretching, gait modification etc.
Age, Continuous	63 years STANDARD_DEVIATION 6 • n=40 Participants
Sex: Female, Male Female	29 Participants n=40 Participants
Sex: Female, Male Male	11 Participants n=40 Participants
Region of Enrollment Hong Kong	40 participants n=40 Participants

PRIMARY outcome

Timeframe: At baseline and one week after intervention

External knee moment in the frontal plane during early stance phase of walking

Outcome measures

Measure	Exercise n=40 Participants Six-week exercise including stretching, strengthening, endurance and gait modification Exercise: Comprehensive exercise program including strengthening, stretching, gait modification etc.
Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System	0.50 Nm/kg Standard Deviation 0.13

SECONDARY outcome

Timeframe: At baseline and one week after intervention

Pain intensity measured by the pain subscale of Knee injury and Osteoarthritis Outcome Score (KOOS). The minimum value is 0 and maximum value is 100. The higher scores mean a better outcome.

Outcome measures

Measure	Exercise n=39 Participants Six-week exercise including stretching, strengthening, endurance and gait modification Exercise: Comprehensive exercise program including strengthening, stretching, gait modification etc.
Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score	70 Score on a scale Standard Deviation 14

SECONDARY outcome

Timeframe: At baseline

The angle between tibial and femur in the transverse plane

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and one week after intervention

Young's modulus by ultrasound elastography

Outcome measures

Outcome data not reported

Adverse Events

Exercise

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

Dr Amy Fu

The Hong Kong Polytechnic University

Phone: 8522766 6726

Email: amy.fu@polyu.edu.hk

Results disclosure agreements

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