Knee Arthritis, OsteoarthritisKORRINCT07424352
Knee Osteoarthritis Rehabilitation Through Rotational Inertia
A study testing Eccentric resistance training in people with Knee Arthritis, Osteoarthritis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Arthritis, Osteoarthritis
- What is being tested?
- Eccentric resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 40-70 years
- Radiographically confirmed knee OA (Kellgren-Lawrence [KL] Grade 2 or 3)
- Able to walk independently (assistive devices permitted)
- Aged 40-70 years
- No radiographic evidence of knee OA (KL Grade 0 or 1)
- No frequent knee pain
Show all 10Show fewer
- No history of:
- Knee surgery (e.g., ACL reconstruction, meniscectomy, patellar realignment)
- Significant knee injury (e.g., ligament tears, fractures, dislocations)
- Diagnosed knee conditions (e.g., patellofemoral pain syndrome, bursitis)
Who cannot join
- Uncontrolled hypertension or other cardiovascular disease
- A musculoskeletal condition preventing physical testing
- Neurological muscle weakness (e.g., stroke, spinal cord injury)
- BMI >34.9 kg/m²
- Recent hospitalization (past 3 months)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Harris-Love, PT, MPT, DSc, FGSA, FAPTA contact
United States1 site, 1 recruiting
- Recruiting
University of Colorado, Denver
Aurora, Colorado, 80045
Katie Boncella, 720-724-1786, katie.boncella@cuanschutz.edu
Michael Harris-Love, PT, MPT, DSc, FGSA, FAPTA
About this study
Official title: Exploring the Benefits of Eccentric Training for Aging Adults With Knee Osteoarthritis
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.
- Conditions
- Knee Arthritis, Osteoarthritis
- Being tested
- Eccentric resistance training
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric resistance trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Eccentric resistance training |
| 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. Receives: Other: Eccentric resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, up to 10 weeks, up to 19 weeks
Secondary outcomes (18)
Stepping smoothness symmetry index
Bilateral differences in smoothness during stair-step negotiation (asymmetry between limbs). Unitless.
Measured: Baseline, up to 10 weeks, up to 19 weeks
Muscle echogenicity
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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 (°).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: Baseline, up to 10 weeks, up to 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start20 Aug 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis, OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- NIH/NCATS Colorado CTSA Grant Number T32TR004367
- Responsible party
- Sponsor
- Investigators
- Michael Harris-Love, PT, MPT, DSc, FGSA, FAPTA, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424352
- Sponsor's protocol ID
- 24-1836
- Other IDs
- T32TR004367
- Acronym
- KORRI
- Status last verified
- Feb 2026
- First submitted
- 22 Oct 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Benefits of Eccentric Training for Aging Adults With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07424352
- Acronym / sponsor ID
- KORRI / 24-1836
- Conditions
- Knee Arthritis, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- NIH/NCATS Colorado CTSA Grant Number T32TR004367
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial-Exercise' | Experimental | Other: Eccentric resistance trainingThe 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. |
| Delayed-Exercise | Experimental | Other: Eccentric resistance trainingThe '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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 40-70 years
- Radiographically confirmed knee OA (Kellgren-Lawrence [KL] Grade 2 or 3)
- Able to walk independently (assistive devices permitted)
- Aged 40-70 years
- No radiographic evidence of knee OA (KL Grade 0 or 1)
Key exclusion criteria (5 listed)
- Uncontrolled hypertension or other cardiovascular disease
- A musculoskeletal condition preventing physical testing
- Neurological muscle weakness (e.g., stroke, spinal cord injury)
- BMI >34.9 kg/m²
- Recent hospitalization (past 3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric resistance trainingThe 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. | Other | Delayed-Exercise, Initial-Exercise' |
Primary outcome
Stair-stepping smoothness
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.
18 secondary outcomes
Stepping smoothness symmetry index
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Muscle echogenicity
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Muscle thickness
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Muscle texture analysis (gray-level co-occurrence matrix)
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Grip strength
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Lower limb strength
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Timed stair ambulation
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Short Physical Performance Battery (SPPB)
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Joint Position
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Joint Linear Velocity
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Joint Linear Acceleration
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Joint Angular Velocity
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Joint Angular Acceleration
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Joint Range of Motion
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Joint Forces
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Joint Moments (Torques)
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Self-reported pain
Time frame: Baseline, up to 10 weeks, up to 19 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Harris-Love, PT, MPT, DSc, FGSA, FAPTA contact
Michael Harris-Love, PT, MPT, DSc, FGSA, FAPTA principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric resistance training in people with Knee Arthritis, Osteoarthritis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Boncella, MS (7207241786, katie.boncella@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stair-stepping smoothness (time frame: Baseline, up to 10 weeks, up to 19 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.