Osteoarthritis, KneeNCT05217420
Moving Well for Total Knee Arthroplasty (TKA)
A study testing Moving Well and Staying Well in people with Osteoarthritis, Knee, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of a behavioral intervention, Moving Well, in improving levels of anxiety and depression for patients undergoing total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Moving Well and Staying Well
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2022to 16 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects must have their primary TKR (one knee or both knees) scheduled in 8 weeks or more
- Be willing to participate in the Moving Well (intervention) arm or Staying Well (attention control) arm
- Are willing to work with a coach
- ≥ 50 years of age
- Speak English
- Have access to the internet, computer, and a working phone
- We will prioritize the recruitment of subjects with low socioeconomic status defined as being a beneficiary of Medicaid or no insurance and an underrepresented racial/ethnic group (Hispanic/Black).
Who cannot join
- Non-English speakers
- The intervention will first be delivered in English to ensure feasibility with the content before adapting the material for patients who speak other languages.
- TKR was a result of a septic joint or revision (implant malfunction)
- Unable to exercise (e.g., bed bound or wheelchair bound)
- Have had contralateral TKR or other joint replacement surgery (hip, shoulder) within the past 5 years
- If they have RA or other connective tissue disease: Lupus, ankylosing spondylitis, psoriatic arthritis, scleroderma, infectious arthritis, polymyalgia rheumatica.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medicine Clinical & Translational Science Center
New York, New York, 10065
About this study
Official title: Moving Well Intervention for Patients Preparing to Undergo Total Knee Arthroplasty (TKA)
The purpose of this study is to assess the efficacy of a behavioral intervention, Moving Well, in improving levels of anxiety and depression for patients undergoing total knee arthroplasty (TKA).
Read the detailed description
Moving Well is a behavioral intervention, guided by peer coaches, that aims to improve mental and physical preparation for patients planning to undergo total knee arthroplasty (TKA) and improve postoperative recovery and outcomes. Peer coaches are patients who themselves have had TKA due to advanced osteoarthritis (OA) of the knee and have been trained and certified to become peer coaches.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Moving Well, Staying Well
- Keywords
- arthroplasty, replacement, peer coach
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moving WellBehavioural
Experimental arm
Staying WellBehavioural
Active comparator arm
| Study group | Role | What they receive |
|---|---|---|
| Moving Well | Experimental | Participants will receive weekly calls for 12 weeks (7 weeks before total knee arthroplasty surgery and 5 weeks after surgery) from a peer coach, an exercise program, and mental preparation (through positive thinking) for surgery. Participants will also receive the standard of care for patients undergoing total knee arthroplasty. Receives: Behavioral: Moving Well |
| Staying Well | Active comparator | Participants will receive weekly calls for 12 weeks (7 weeks before total knee arthroplasty surgery and 5 weeks after surgery) from a research assistant. The calls will be similar in length to those in the experimental arm and will cover various health topics not related to total knee arthroplasty. Participants will also receive the standard of care for patients undergoing total knee arthroplasty. Receives: Behavioral: Staying Well |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of anxiety from baseline using the Generalized Anxiety Disorder Assessment (GAD-7)
The GAD-7 is a 7 item self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Scores range from 0 to 21, with higher scores indicating greater severity of anxiety.
Measured: Baseline, 6 months post-surgery
Change in level of depression from baseline using the Patient Health Questionnaire-8 (PHQ-8)
The PHQ-8 is a 8 item scale that screens for depression. Scores range from 0 to 24 with higher scores indicating greater severity of depression.
Measured: Baseline, 6 months post-surgery
Secondary outcomes (13)
Change in level of social support from baseline using the Lubben Social Network Scale-18 (LSNS-18)
The LSNS-18 is a 18 item scale that measures perceived social support. Scores range from 0 to 90 with higher scores indicating greater social engagement.
Measured: Baseline, 6 months post-surgery
Change in general health status from baseline using the 12-Item Short Form Survey (SF-12)
The SF-12 is a 12 item scale that assesses general health status. Scores range from 0 to 100 with higher scores indicating better physical and mental health functioning.
Measured: Baseline, 6 months post-surgery
Change in level of pain catastrophizing from baseline using the Pain Catastrophizing Scale (PCS).
The PCS is a 13 item scale that assesses the level of catastrophic thinking related to an individual's pain. Scores range from 0 to 52 with higher scores indicating a higher level of pain-related anxiety.
Measured: Baseline, 6 months post-surgery
Change in level of knee pain and function from baseline using the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale.
The KOOS pain sub-scale is a 9 item scale that assesses knee pain. Scores range from 0 to 100 with lower scores indicating greater severity of pain. The KOOS function sub-scale is a 17 item scale that assesses function. Scores range from 0 to 100 with lower scores indicating worse knee function.
Measured: Baseline, 6 months post-surgery
Change in level of self-efficacy from baseline using the General Self-Efficacy Scale (GSF)
The GSF is a 10 item scale that assesses perceived self-efficacy. Scores range from 10 to 40 with higher scores indicating a higher level of self-efficacy.
Measured: Baseline, 6 months post-surgery
Change in sleep disturbance from baseline using the Patient-Reported Outcomes Information System (PROMIS) Sleep Disturbance Scale.
The PROMIS Sleep Disturbance Scale is a 8 item scale that measure self-reported perceptions of sleep quality, depth, and restoration within the past seven days. Scores range from with higher scores indicating greater sleep disturbances.
Measured: Baseline, 6 months post-surgery
Change in opioid use for knee pain from baseline using participant self-report
Self-reported use of opioids for knee pain
Measured: Baseline, 6 months post-surgery
Duration of post-surgery inpatient rehabilitation using the number of days of inpatient rehabilitation
Self-reported duration of inpatient rehabilitation
Measured: 6 months post-surgery
Change in knee range of motion from baseline using a goniometer
A goniometer measures the range of motion at a joint. Measurement ranges from 0 to 180 degrees with higher range indicating greater range of motion.
Measured: Baseline, 6 months post-surgery
Change in Timed Up and Go test (TUG) from baseline
The Timed Up and Go test is used to assess mobility. Completing the test in more than 12 seconds indicates a greater risk of falling in older adults.
Measured: Baseline, 6 months post-surgery
Change in 6-minute walk test (6MWT) from baseline
The 6MWT is used to assess aerobic capacity and endurance. The distance covered by walking for 6 minutes is measured and used to compare changes in performance capacity.
Measured: Baseline, 6 months post-surgery
Change in 30-second chair to stand test from baseline
The 30-second chair to stand test assesses leg strength and endurance. Scoring is based on the number of stands with a lower than average number indicating a greater risk of falls.
Measured: Baseline, 6 months post-surgery
Change in quadriceps strength from baseline using a handheld dynamometer (HHD)
A handheld dynamometer is a device that measures muscle strength. Scores range from 0-300 pounds (upper limit can vary based on the device) with higher scores indicating greater quadriceps muscle strength.
Measured: Baseline, 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start5 Apr 2022
- Primary completion16 Jan 2025
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Rheumatology Research Foundation, Hospital for Special Surgery, New York
- Responsible party
- Sponsor
- Investigators
- Iris Y Navarro Millan, MD, MSPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217420
- Sponsor's protocol ID
- 19-08020638
- Status last verified
- Jul 2026
- First submitted
- 31 Jan 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jabri A, Dominguez Paez Y, Brown M, Lui G, Hui WK, Hernandez N, Parks ML, Gonzalez Della Valle A, Goodman SM, Banerjee S, Safford MM, Navarro-Millan I. A single-center, open-label, randomized, parallel-group trial to pilot the effectiveness of a peer coach behavioral intervention versus an active control in reducing anxiety and depression in patients scheduled for total knee replacement. BMC Musculoskelet Disord. 2023 May 5;24(1):353. doi: 10.1186/s12891-023-06460-4.
PubMed 37147587
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moving Well Intervention for Patients Preparing to Undergo Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT05217420
- Acronym / sponsor ID
- 19-08020638
- Conditions
- Osteoarthritis, Knee
- Keywords
- arthroplasty, replacement, peer coach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Rheumatology Research Foundation, Hospital for Special Surgery, New York
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 1 Feb 2022 (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 purpose of this study is to assess the efficacy of a behavioral intervention, Moving Well, in improving levels of anxiety and depression for patients undergoing total knee arthroplasty (TKA).
Detailed description
Moving Well is a behavioral intervention, guided by peer coaches, that aims to improve mental and physical preparation for patients planning to undergo total knee arthroplasty (TKA) and improve postoperative recovery and outcomes. Peer coaches are patients who themselves have had TKA due to advanced osteoarthritis (OA) of the knee and have been trained and certified to become peer coaches.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moving Well | Experimental | Behavioral: Moving WellParticipants will receive weekly calls for 12 weeks (7 weeks before total knee arthroplasty surgery and 5 weeks after surgery) from a peer coach, an exercise program, and mental preparation (through positive thinking) for surgery. Participants will also receive the standard of care for patients undergoing total knee arthroplasty. |
| Staying Well | Active comparator | Behavioral: Staying WellParticipants will receive weekly calls for 12 weeks (7 weeks before total knee arthroplasty surgery and 5 weeks after surgery) from a research assistant. The calls will be similar in length to those in the experimental arm and will cover various health topics not related to total knee arthroplasty. Participants will also receive the standard of care for patients undergoing total knee arthroplasty. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must have their primary TKR (one knee or both knees) scheduled in 8 weeks or more
- Be willing to participate in the Moving Well (intervention) arm or Staying Well (attention control) arm
- Are willing to work with a coach
- ≥ 50 years of age
- Speak English
Key exclusion criteria (6 listed)
- Non-English speakers
- The intervention will first be delivered in English to ensure feasibility with the content before adapting the material for patients who speak other languages.
- TKR was a result of a septic joint or revision (implant malfunction)
- Unable to exercise (e.g., bed bound or wheelchair bound)
- Have had contralateral TKR or other joint replacement surgery (hip, shoulder) within the past 5 years
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 |
|---|---|---|
| Moving WellExperimental arm | Behavioural | Moving Well |
| Staying WellActive comparator arm | Behavioural | Staying Well |
Primary outcome
Change in level of anxiety from baseline using the Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: Baseline, 6 months post-surgery
The GAD-7 is a 7 item self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Scores range from 0 to 21, with higher scores indicating greater severity of anxiety.
Change in level of depression from baseline using the Patient Health Questionnaire-8 (PHQ-8)
Time frame: Baseline, 6 months post-surgery
The PHQ-8 is a 8 item scale that screens for depression. Scores range from 0 to 24 with higher scores indicating greater severity of depression.
13 secondary outcomes
Change in level of social support from baseline using the Lubben Social Network Scale-18 (LSNS-18)
Time frame: Baseline, 6 months post-surgery
Change in general health status from baseline using the 12-Item Short Form Survey (SF-12)
Time frame: Baseline, 6 months post-surgery
Change in level of pain catastrophizing from baseline using the Pain Catastrophizing Scale (PCS).
Time frame: Baseline, 6 months post-surgery
Change in level of knee pain and function from baseline using the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale.
Time frame: Baseline, 6 months post-surgery
Change in level of self-efficacy from baseline using the General Self-Efficacy Scale (GSF)
Time frame: Baseline, 6 months post-surgery
Change in sleep disturbance from baseline using the Patient-Reported Outcomes Information System (PROMIS) Sleep Disturbance Scale.
Time frame: Baseline, 6 months post-surgery
Change in opioid use for knee pain from baseline using participant self-report
Time frame: Baseline, 6 months post-surgery
Duration of post-surgery inpatient rehabilitation using the number of days of inpatient rehabilitation
Time frame: 6 months post-surgery
Change in knee range of motion from baseline using a goniometer
Time frame: Baseline, 6 months post-surgery
Change in Timed Up and Go test (TUG) from baseline
Time frame: Baseline, 6 months post-surgery
Change in 6-minute walk test (6MWT) from baseline
Time frame: Baseline, 6 months post-surgery
Change in 30-second chair to stand test from baseline
Time frame: Baseline, 6 months post-surgery
Change in quadriceps strength from baseline using a handheld dynamometer (HHD)
Time frame: Baseline, 6 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Derived from this study: PubMed 37147587Jabri A, Dominguez Paez Y, Brown M, Lui G, Hui WK, Hernandez N, Parks ML, Gonzalez Della Valle A, Goodman SM, Banerjee S, Safford MM, Navarro-Millan I. A single-center, open-label, randomized, parallel-group trial to pilot the effectiveness of a peer coach behavioral intervention versus an active control in reducing anxiety and depression in patients scheduled for total knee replacement. BMC Musculoskelet Disord. 2023 May 5;24(1):353. doi: 10.1186/s12891-023-06460-4.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Iris Y Navarro Millan, MD, MSPH 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 Moving Well and Staying Well in people with Osteoarthritis, Knee, 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 3 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of anxiety from baseline using the Generalized Anxiety Disorder Assessment (GAD-7) (time frame: Baseline, 6 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05217420, which also lists 1 linked publication.
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 3 Aug 2026.