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| ID | Type | Description | Link |
|---|---|---|---|
| T32TR004367 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| NIH/NCATS Colorado CTSA Grant Number T32TR004367 | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial-Exercise' | Experimental | The initial exercise group will participate in an 8-week eccentric overload exercise intervention using a kBox, with two sessions per week. Participants will then cease the intervention for 8 weeks to enter a detraining period. |
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| Delayed-Exercise | Experimental | The 'Delayed-Exercise' group will maintain their normal activity, without intervention, for the first 8 weeks of the study. In the second half of the study, they will begin the same 8-week kBox training completed by the 'Initial-Exercise' group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eccentric resistance training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stair-stepping smoothness | 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. | Baseline, up to 10 weeks, up to 19 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stepping smoothness symmetry index | Bilateral differences in smoothness during stair-step negotiation (asymmetry between limbs). Unitless. | Baseline, up to 10 weeks, up to 19 weeks |
| Muscle echogenicity |
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Inclusion Criteria Osteoarthritis (OA) Group:
Inclusion Criteria Healthy Control Group:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katie Boncella, MS | Contact | 7207241786 | katie.boncella@cuanschutz.edu | |
| Michael Harris-Love, PT, MPT, DSc, FGSA, FAPTA | Contact | 303-724-0687 | michael.harris-love@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Harris-Love, PT, MPT, DSc, FGSA, FAPTA | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Denver | Recruiting | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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.
| Baseline, up to 10 weeks, up to 19 weeks |
| Muscle thickness | Muscle thickness is a non-invasive ultrasound measure obtained as the distance between superficial and deep muscle borders. Units: mm. | Baseline, up to 10 weeks, up to 19 weeks |
| Muscle texture analysis (gray-level co-occurrence matrix) | 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. | Baseline, up to 10 weeks, up to 19 weeks |
| Grip strength | Grip strength is objectively measured using a handheld dynamometer, recording the maximal isometric force over three trials. Units: kg. | Baseline, up to 10 weeks, up to 19 weeks |
| Lower limb strength | 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. | Baseline, up to 10 weeks, up to 19 weeks |
| Timed stair ambulation | 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. | Baseline, up to 10 weeks, up to 19 weeks |
| Short Physical Performance Battery (SPPB) | 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. | Baseline, up to 10 weeks, up to 19 weeks |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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. | Baseline, up to 10 weeks, up to 19 weeks |
| Joint Position | Linear joint position measured using an optical tracking system during dynamic tasks. Unit of Measure: Meters (m) | Baseline, up to 10 weeks, up to 19 weeks |
| Joint Linear Velocity | Linear joint velocity derived from optical tracking data during dynamic tasks. Unit of Measure: Meters per second (m/s) | Baseline, up to 10 weeks, up to 19 weeks |
| Joint Linear Acceleration | Linear joint acceleration derived from optical tracking data during dynamic tasks. Unit of Measure: Meters per second squared (m/s²). | Baseline, up to 10 weeks, up to 19 weeks |
| Joint Angular Velocity | Angular velocity of the joint measured during dynamic tasks using optical tracking systems. Unit of Measure: Radians per second (rad/s) | Baseline, up to 10 weeks, up to 19 weeks |
| Joint Angular Acceleration | Angular acceleration of the joint measured during dynamic tasks using optical tracking systems. Unit of Measure: Radians per second squared (rad/s²). | Baseline, up to 10 weeks, up to 19 weeks |
| Joint Range of Motion | Active joint range of motion measured in the sagittal, frontal, and transverse planes during dynamic tasks using optical tracking systems. Unit of Measure: Degrees (°). | Baseline, up to 10 weeks, up to 19 weeks |
| Joint Forces | 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). | Baseline, up to 10 weeks, up to 19 weeks |
| Joint Moments (Torques) | 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) | Baseline, up to 10 weeks, up to 19 weeks |
| Self-reported pain | 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. | Baseline, up to 10 weeks, up to 19 weeks |