University of Colorado, Denver
Aurora, Colorado, 80045, United States
Location status: Recruiting
Location contact
Katie Boncella
CONTACT
Michael Harris-Love, PT, MPT, DSc, FGSA, FAPTA
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07424352
This study is testing whether a new type of exercise program, called eccentric overload training using a flywheel device, can improve stair-climbing ability in people with knee osteoarthritis. The flywheel device provides resistance throughout the entire movement and gives extra challenge during the muscle-lengthening phase of exercise. This type of training may improve muscle structure, strength, and coordination more effectively than conventional methods.
The study's central idea is that better muscle quality and improved coordination will lead to smoother, safer stair movement and reduce the risk of falls. Advanced tools such as ultrasound imaging and motion analysis will be used to measure muscle health and movement patterns in detail.
The hypothesis is that individuals with knee osteoarthritis have poorer muscle quality and less coordinated stair-stepping compared to healthy adults, and that performing eccentric overload training will enhance muscle quality, improve movement coordination, and make stair navigation safer and more efficient.
Interested in participating?
Request Info40 year–70 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
Location status: Recruiting
Katie Boncella
CONTACT
Michael Harris-Love, PT, MPT, DSc, FGSA, FAPTA
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Osteoarthritis (OA) Group:
Inclusion criteria
Healthy Control Group:
Exclusion criteria
The intervention consists of an eccentric overload resistance training program using a portable flywheel exercise device (kBox). This device generates resistance through inertia, meaning that the load is created by the individual's own movement speed and the effort applied. Participants with knee osteoarthritis will train with the flywheel system for 8 weeks, completing two to three sessions each week, with each session lasting approximately 30 to 45 minutes. The program will focus on functional lower-limb exercises such as squats, step-ups, and knee extensions. These exercises are chosen because they closely mimic everyday movements like climbing and descending stairs. Participants randomized to the delayed-exercise subgroup will continue with usual activity and medical care for the first 8 weeks, serving as a comparison group. After this waiting period, the delayed group will then be offered the same flywheel training protocol.
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Stair-stepping smoothness quantifies motor coordination during the step-up-and-over test by analyzing the fluidity and consistency of limb movements while ascending and descending stairs. It is calculated using a jerk-based smoothness metric adapted from Gonzales et al., where jerk is defined as the third derivative of the position trajectory with respect to time. The smoothness index is derived by numerically differentiating the position data x(t) obtained from motion capture three times to calculate jerk, then squaring and summing these jerk values over the duration of the movement. Lower values of the smoothness index indicate smoother, more coordinated movements. Differences in this metric will be compared between knee osteoarthritis patients and age-matched healthy controls, with variance explained through linear regression models, and between exercise intervention and delayed exercise subgroups to assess changes in motor control during stair negotiation. Unitless.
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Bilateral differences in smoothness during stair-step negotiation (asymmetry between limbs). Unitless.
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Muscle echogenicity is measured via diagnostic ultrasound, which quantifies the brightness intensity (greyscale pixel values) of muscle tissue images to provide a non-invasive assessment of muscle composition and quality. Unitless.
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Muscle thickness is a non-invasive ultrasound measure obtained as the distance between superficial and deep muscle borders. Units: mm.
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Muscle texture analysis using gray-level co-occurrence matrix (GLCM) is an advanced ultrasound imaging technique that quantitatively assesses the spatial distribution and relationship of pixel intensities within a muscle. Unitless.
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Grip strength is objectively measured using a handheld dynamometer, recording the maximal isometric force over three trials. Units: kg.
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Lower limb strength assessment are completed using the Biodex system involves isokinetic and isometric dynamometry to quantify maximal voluntary muscle force during knee extension and flexion. Units: Newton-meters.
Time frame: Baseline, up to 10 weeks, up to 19 weeks
The Timed Stair Ambulation test measures the time taken for an individual to ascend and descend a flight of stairs, reflecting lower limb muscle power, functional mobility, and endurance. The outcome is the recorded time in seconds to complete the stair climb task, with lower times indicating better physical performance and function. Units: seconds.
Time frame: Baseline, up to 10 weeks, up to 19 weeks
The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity physical function using three timed tests: standing balance, 4-meter usual-paced walk, and five repeated chair stands. Each component is scored from 0 to 4 points, yielding a total score range from 0 to 12, where higher scores indicate better physical performance and lower disability.
Time frame: Baseline, up to 10 weeks, up to 19 weeks
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a patient-reported questionnaire evaluating Osteoarthritis-related pain, stiffness, and physical function with subscale score ranges: Pain (0-20), Stiffness (0-8), and Physical Function (0-68). Higher scores indicate worse symptoms and greater disability. The total score sums all subscales, ranging from 0 to 96, with higher values representing more severe osteoarthritis impact.
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Linear joint position measured using an optical tracking system during dynamic tasks. Unit of Measure: Meters (m)
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Linear joint velocity derived from optical tracking data during dynamic tasks. Unit of Measure: Meters per second (m/s)
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Linear joint acceleration derived from optical tracking data during dynamic tasks.
Unit of Measure: Meters per second squared (m/s²).
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Angular velocity of the joint measured during dynamic tasks using optical tracking systems. Unit of Measure: Radians per second (rad/s)
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Angular acceleration of the joint measured during dynamic tasks using optical tracking systems. Unit of Measure: Radians per second squared (rad/s²).
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Active joint range of motion measured in the sagittal, frontal, and transverse planes during dynamic tasks using optical tracking systems. Unit of Measure: Degrees (°).
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Net joint forces calculated using inverse dynamics during dynamic tasks. These measures reflect the mechanical loads experienced at the joint. Unit of Measure: Newtons (N).
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Net joint moments calculated using inverse dynamics during dynamic tasks. These measures reflect the rotational loads acting about the joint and provide insight into muscle performance and load distribution. Unit of Measure: Newton-meters (N·m)
Time frame: Baseline, up to 10 weeks, up to 19 weeks
The Visual Analog Scale (VAS) is a unidimensional measure used to assess pain intensity. It consists of a 10-centimeter horizontal line with anchors at each end labeled "no pain" (0) and "worst pain imaginable" (10). Patients mark a point on the line corresponding to their pain level, which is measured in millimeters from the zero end. Higher scores indicate greater pain intensity. This scale provides a continuous range allowing sensitive detection of changes in pain over time.
Contact information is provided by the study sponsor or research team.
Katie Boncella, MS
CONTACT
Michael Harris-Love, PT, MPT, DSc, FGSA, FAPTA
CONTACT
University of Colorado, Denver
Other
Exploring the Benefits of Eccentric Training for Aging Adults With Knee Osteoarthritis
Acronym: KORRI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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