An interventional study of I'm Walking and Walk With Ease in Osteoarthritis, sponsored by Weill Medical College of Cornell University. Not yet recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment
Among 1,029 studies in Osteoarthritis with a site in United States — 117 open to participants now, 177 under way, 14 of them phase 3. Osteoarthritis · United States.
Among the 1,029 studies in Osteoarthritis with a site in United States, this one is the 260th largest by planned enrollment of the 832 interventional ones, is one of 37 that started in 2026, is one of 437 with no phase, reaches primary completion later than 132 of the 176 other live ones, and was the 1,027th registered.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →117 of the 1,029 studies in Osteoarthritis with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 287 Osteoarthritis studies recruiting now, 158 (55%) set no upper age limit and 72 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →1,029 studies; the count open now beside each. This study's row is marked.
First in 1977; this study’s year is marked. 37 started in 2026.
Median enrollment 100 across the 832 interventional studies, 114 across the 188 observational. Of the 758 that completed or were terminated, 338 (45%) have results posted.
473 of 1,029 have an industry lead sponsor. The 10 most frequent:
Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Weill Medical College of Cornell University has 1 study filed under Osteoarthritis — fewer than ten, so there is no comparison to draw.
60 of the studies in Osteoarthritis with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06269705Phase 3Pacira Pharmaceuticals, IncZILRETTA in Subjects With Shoulder Osteoarthritis | 2026-12 |
| NCT05992883Phase 3Mayo ClinicNSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis | 2026-12-31 |
| NCT07219771Phase 3Doron Therapeutics Inc.A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients (MOTION-P) | 2027-06-30 |
| NCT06917404Phase 3Paradigm Biopharmaceuticals Ltd.A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain. | 2027-07 |
| NCT06003101Phase 3Massachusetts General HospitalEffect of PRP, PPP, & BMAC on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies | 2027-08-30 |
Among the 1,029 studies in Osteoarthritis with a site in United States, from their registry updates:
The goal of this clinical trial is to learn if a behavioral program called I'M Walking will help with pain in middle-aged and older adults.
Researchers will compare the I'M Walking program with a Walk With Ease program (self-directed program)
Randomized controlled trial evaluating the I'M Walking program vs the Walk With Ease (WWE) program for older adults with symptomatic knee osteoarthritis.
All participants will receive treatment for 3 months and complete a 3-month follow-up period. Data collection will occur at baseline, post-treatment (month 3), and at the end of the follow-up period (month 6).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the I'M Walking arm will gain access to a website with 8 modules of a mindfulness-based intervention (MBI) which will include videos and a written manual with worksheets for practice and additional resources.
Behavioral: I'm Walking
Participants in the Walk With Ease arm will be directed to use the publicly available WWE self-directed online program.
Other: Walk With Ease
Participants in the I'M Walking arm will gain access to a website with 8 modules of a mindfulness-based intervention (MBI) which will include videos and a written manual with worksheets for practice and additional resources. Modules include information regarding integrating mindfulness into walking exercises, meditation practices, and mind-body awareness. The MBI is intended to reduce pain interference and encourage increased physical activity. The study team anticipates that each module will take approximately 45 minutes to complete, for a total of 360 minutes. A physical therapist will monitor patients' steps on the ExerciseRx app dashboard and will coach patients through completion of the 8 MBI modules. Through 4, 45-minute phone calls or videoconferences, the physical therapist will address patient concerns to implementing the MBI skills into their daily life and counsel them to increase physical activity through walking.
Participants in the Walk With Ease arm will be directed to use the publicly available WWE self-directed online program. Study staff will assist participants in making an account on the Osteoarthritis Action Alliance website where they can access the WWE book, videos, and interactive activity tracking modules. They will be instructed to complete 1 chapter per week. The WWE program is widely disseminated and available for older adults with osteoarthritis. A trained health educator will meet with each patient for 4, 30-45-minute phone calls and/or videoconferences to discuss the WWE program, answer questions, and provide arthritis education regarding pain management, exercise, and sleep.
Difference between groups in pain interference as measured by PROMIS Pain Interference (PI) Short Form 8a at week 24
Pain interference will be measured by the 8-item PROMIS Short Form 8a Pain Interference measure. This measure assesses how much pain disrupts a person's daily activities and enjoyment of life over the past 7 days. Each question is a 5-point likert scale from 1 (Not at all) to 5 (Very much) with a higher score indicating more pain interference. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 40.7 to 77.0. Lower T-scores represent better outcomes.
Time frame: Week 24
Difference between groups in pain intensity (Brief Pain Inventory Pain Intensity Subscale) at Week 24
Patient-reported pain intensity will be measured by the 4-item Brief Pain Inventory Pain Intensity Subscale. This assess the severity of pain and impact on mood, walking, and other daily activities. Each question is an 11-point numeric reading scale from 0 (no pain) to 10 (pain as bad as you can imagine), the overall score range is 0 to 40 with a higher score indicating higher pain intensity.
Time frame: Week 24
Difference between groups in physical function (PROMIS Physical Function Short Form 6b) at week 24
Patient-reported difficulty with activities of daily living as measured by the 6-item PROMIS Physical Functioning Short Form 6b. This measures a person's ability to perform activities such as chores, activities of daily living, and climbing stairs. Each question is a five-point likert scale from 5 (without any difficulty) to 1 (unable to do) with a lower score indicating lower physical function. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 21.0 to 59.0. Higher T-scores represent better outcomes.
Time frame: Week 24
Difference between groups in depressive symptoms (Patient Health Questionnaire; PHQ-8) at week 24
Depressive Symptoms will be measured by PHQ-8 (Patient Health Questionnaire). This 8-item instruments measures symptoms of depression over the past 2 weeks such as, 'feeling down, depressed, or hopeless' or 'poor appetite or overeating'. Respondents report level of depression symptoms on a 4-point scale from 0 (Not at all) to 3 (Nearly every day). The overall score range is 0 to 24 with a higher score indicating higher depressive symptoms.
Time frame: Week 24
Difference between groups in anxiety symptoms (Generalized Anxiety Disorder; GAD-7) at week 24
Anxiety Symptoms will be measured by GAD-7 (Generalized Anxiety Disorder-7). This 7-item instruments measures symptoms of anxiety over the past 2 weeks such as, 'feeling nervous, anxious, or on edge', 'trouble relaxing'. Respondents report level of anxiety symptoms on a 4-point scale from 0 (Not at all) to 3 (Nearly every day). The overall score range is 0 to 21 with a higher score indicating higher anxiety symptoms.
Time frame: Week 24
Difference between groups in treatment satisfaction (Patient Global Impression of Change; PGIC) at week 24
Patient-reported global impression of change as measured by 1-item PGIC scale. This assesses the patient's overall perception of improvement or worsening of their symptoms since the start of the study on a 7-point likert scale from very much improved (1) to very much worse (7) with a higher score indicating greater perceived improvement.
Time frame: Week 24
Difference between groups in knee pain (Knee Injury and Osteoarthritis Outcome Score, KOOS pain subscale) at week 24
Knee pain will be measured by KOOS pain subscale consisting of 9-items. Each question is a 5-point likert score from 0 (no problems) to 5 (extreme problems). Scores are then calculated to a scale of 0-100 with a higher score indicating better pain.
Time frame: Week 24
Difference between groups in knee function (Knee Injury and Osteoarthritis Outcome Score, KOOS function subscale) at week 24
Knee function will be measured by KOOS function in daily living (ADL) subscale consisting of 17-items. Each question is a 5-point likert score from 0 (no problems) to 5 (extreme problems). Scores are then calculated to a scale of 0-100 with a higher score indicating better function.
Time frame: Week 24
Difference between groups in sleep disturbance (PROMIS Sleep Disturbance Short Form 6a) at Week 24
Patient-reported sleep disturbance as measured by the 6-item PROMIS Sleep Disturbance Short Form 6a. This measures a person's sleep disturbance such as quality, difficulty falling asleep, restless. Each question is a five-point likert scale from 5 (very poor or not at all) to 1 (very good or very much) with a lower score indicating lower sleep disturbance (2 reverse scored questions). In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 31.7 to 76.1. Higher T-scores represent better sleep disturbance outcomes.
Time frame: Study week 24
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Informed consent form
Time frame: Beginning 6 months and ending 5 years following article publication.
Access criteria: Researchers who provide a methodologically sound proposal.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2028, 19 months later.
Of 578 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's planned 19 months is below that.
Counting every sponsor, half of 713 studies reached it within 29 months; a quarter within 11 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University →