Clinical trial NCT04139161: Cycling Intervention on Symptoms of Patients With Knee Osteoarthritis
Official title: Cycling Intervention on Symptoms of Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Men and Women between the ages of 50 and 75 years old.
* Diagnosed with medial compartment tibiofemoral osteoarthritis in one of their knees.
* Be able to walk unaided for at least 25 consecutive minutes.
* Present with knee pain for at least 6 months occurring on a majority of the days in the month, or on most days (more than or equal to 4 of 7 days in a week) in one or both knees for at least 4 months.
* Osteophytes on knee x-rays.
* Grade 2 or higher out of a maximum of 4 on a modified Kellgren/Lawrence grade on the knee radiograph.

Exclusion Criteria:

* Initial Visual Analog Scale pain scores greater than 7.
* Diagnosed osteoarthritis of ankles, hips, or symptomatic osteoarthritis of the spine.
* Arthroplasty of any other lower extremity joint.
* BMI value greater than 40 kg/m2.
* Any major lower extremity injury in the past 6 months.
* Systemic Inflammatory Arthritis.
* Systemic Pain Conditions.
* Neurological Conditions that impact gait or cycling.
* Pregnant or Nursing Women.
* Major cardiovascular disease with an exercise limitation prescribed by a physician.
* Steroid injection at the knee within the previous 3 months.

Primary outcomes:
measure: Knee Abduction Moment - Cycling
timeFrame: Baseline, 1 month, 2 month
measure: Knee Abduction Moment - Gait
timeFrame: Baseline, 1 month, 2 month
Secondary outcomes:
measure: Visual Analog Pain
timeFrame: Immediately following exercise (walking and cycling).
measure: Knee Extension Moment - Cycling
timeFrame: Baseline, 1 month, 2 month
measure: Knee Extension Moment - Gait
timeFrame: Baseline, 1 month, 2 month
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Baseline, 1 month, 2 month
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Biomechanics/Sports Medicine Lab
state: Tennessee
Study officials:
affiliation: University of Tennessee, Knoxville
name: Tanner Thorsen, MS
role: PRINCIPAL_INVESTIGATOR
References: