OsteoarthritisSCOAPNCT07896473
Study Comparing Osteoarthritis Programs
A study testing I'm Walking and Walk With Ease in people with Osteoarthritis, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
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. Does the program improve pain interference in participants with knee osteoarthritis? What other factors may affect pain interference with participants that did the intervention?… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- I'm Walking and Walk With Ease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Jun 2028
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥50 years
- Community-dwelling
- ICD-10 codes for knee Osteoarthritis in electronic health record
- Moderate to severe chronic pain using Graded Chronic Pain Scale-Revised (PEG score ≥4)
- Knee pain-related difficulty with walking or climbing stairs
- Owns a smart phone
Who cannot join
- Dementia (ICD-10 codes in EHR or T-MoCA score<13)
- Unable to independently walk a quarter mile
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elise V Hoffman, MPH contact
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
Kushang V Patel, MPH, PhD, 206-616-8052, kvpatel@uw.edu
Kushang V Patel, MPH, PhD
About this study
Official title: Evaluation of the Integrated Mindfulness Walking (I'M Walking) Program for Older Primary Care Patients With Knee Osteoarthritis
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.
- Does the program improve pain interference in participants with knee osteoarthritis?
- What other factors may affect pain interference with participants that did the intervention?
Researchers will compare the I'M Walking program with a Walk With Ease program (self-directed program)
Read the detailed description
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).
- Conditions
- Osteoarthritis
- Being tested
- I'm Walking, Walk With Ease
- Keywords
- osteoarthritis, knee OA, older adults, mindfulness
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I'm WalkingBehavioural
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.
Walk With EaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| I'm Walking | Experimental | 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. Receives: Behavioral: I'm Walking |
| Walk With Ease | Active comparator | Participants in the Walk With Ease arm will be directed to use the publicly available WWE self-directed online program. Receives: Other: Walk With Ease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Study week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Cary Reid, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896473
- Sponsor's protocol ID
- STUDY00023148
- Other IDs
- P30AG022845
- Acronym
- SCOAP
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Integrated Mindfulness Walking (I'M Walking) Program for Older Primary Care Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07896473
- Acronym / sponsor ID
- SCOAP / STUDY00023148
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, knee OA, older adults, mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- University of Washington, National Institute on Aging (NIA)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Oct 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.
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.
- Does the program improve pain interference in participants with knee osteoarthritis?
- What other factors may affect pain interference with participants that did the intervention?
Researchers will compare the I'M Walking program with a Walk With Ease program (self-directed program)
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I'm Walking | Experimental | Behavioral: I'm WalkingParticipants 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. |
| Walk With Ease | Active comparator | Other: Walk With EaseParticipants in the Walk With Ease arm will be directed to use the publicly available WWE self-directed online program. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥50 years
- Community-dwelling
- ICD-10 codes for knee Osteoarthritis in electronic health record
- Moderate to severe chronic pain using Graded Chronic Pain Scale-Revised (PEG score ≥4)
- Knee pain-related difficulty with walking or climbing stairs
Key exclusion criteria (2 listed)
- Dementia (ICD-10 codes in EHR or T-MoCA score<13)
- Unable to independently walk a quarter mile
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 |
|---|---|---|
| I'm WalkingParticipants 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. | Behavioural | I'm Walking |
| Walk With EaseParticipants 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. | Other | Walk With Ease |
Primary outcome
Difference between groups in pain interference as measured by PROMIS Pain Interference (PI) Short Form 8a at week 24
Time frame: 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.
8 secondary outcomes
Difference between groups in pain intensity (Brief Pain Inventory Pain Intensity Subscale) at Week 24
Time frame: Week 24
Difference between groups in physical function (PROMIS Physical Function Short Form 6b) at week 24
Time frame: Week 24
Difference between groups in depressive symptoms (Patient Health Questionnaire; PHQ-8) at week 24
Time frame: Week 24
Difference between groups in anxiety symptoms (Generalized Anxiety Disorder; GAD-7) at week 24
Time frame: Week 24
Difference between groups in treatment satisfaction (Patient Global Impression of Change; PGIC) at week 24
Time frame: Week 24
Difference between groups in knee pain (Knee Injury and Osteoarthritis Outcome Score, KOOS pain subscale) at week 24
Time frame: Week 24
Difference between groups in knee function (Knee Injury and Osteoarthritis Outcome Score, KOOS function subscale) at week 24
Time frame: Week 24
Difference between groups in sleep disturbance (PROMIS Sleep Disturbance Short Form 6a) at Week 24
Time frame: Study week 24
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 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Elise V Hoffman, MPH contact
Cary Reid, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I'm Walking and Walk With Ease in people with Osteoarthritis, run by Weill Medical College of Cornell University 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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 27 Oct 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 Kushang V Patel, PhD, MPH (206-616-8052, kvpatel@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between groups in pain interference as measured by PROMIS Pain Interference (PI) Short Form 8a at week 24 (time frame: Week 24). 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 27 Oct 2026.