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UnknownNCT04139161

Cycling Intervention on Symptoms of Patients With Knee Osteoarthritis

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
The University of Tennessee, Knoxville · Academic / Other
Sex
All
Age
50 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This study is designed to determine the effect of a cycling training program which modulates frontal and sagittal plane knee joint loading with graded increases of Q-Factor and cycling workrate in persons with symptomatic knee osteoarthritis.

Detailed description

The knee joint is one of the most common joints affected by osteoarthritis, and knee osteoarthritis is primarily observed in the medial compartment. This is in part attributable to the increased load experienced by the medial compartment during level walking. Patients with symptomatic knee osteoarthritis exhibit altered gait mechanics; namely a reduced loading response knee extension moment and an increased internal knee abduction moment. As a surrogate measure for medial compartment joint loading, loading response knee abduction moment in level walking has been shown to increase with the severity of knee osteoarthritis. Recent gait modification research has shown that increased step-width decreases peak Knee abduction moment for persons with knee osteoarthritis. The inter-pedal width of a bicycle or cycle ergometer, known as Q-Factor, is analogous in cycling to step-width in gait. In contrast to gait, increased Q-Factor has been shown to increase the knee abduction moment during stationary cycling. Modulating sagittal and frontal plane loading of the knee in a graded manner during cycling may promote healthy adaptation to muscle weakness and pain. This adaptation may be manifest through restoration of altered knee joint biomechanics (knee extension moment, knee abduction moment), which, in turn, may also provide benefit to gait mechanics.

Conditions

Interventions

TypeNameDescription
PROCEDUREQ-Factor InterventionThe intervention period will consist of 12 training sessions across four consecutive weeks, with three training sessions held per week. If pain is not increased or reduced and Rating of Perceived Exertion is ≤12, the participant will progress to the next bout. If pain is increased from the pre-bout pain score, participants will repeat the bout, at the same workrate and Q-Factor settings. Following this fashion, participants will progress through three increasing Q-Factors for each given workrate; Q-Factor 1 (Q1, 192mm), Q2 (234mm), Q3 (276mm). After completing bouts of all three Q-Factors for a given workrate, workrate will be increased by 20 Watts and bouts at each Q-Factor will be repeated. For each training session, participants will complete bouts of cycling until 1) the maximum number of bouts (4 bouts) has been accomplished, 2) self-reported Rating of Perceived Exertion \>12, indicating a transition to moderate physical activity, or 3) self-reported pain \>5.

Timeline

Start date
2019-12-17
Primary completion
2021-05-31
Completion
2021-05-31
First posted
2019-10-25
Last updated
2020-04-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04139161. Inclusion in this directory is not an endorsement.