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NCT Number: NCT05217420

Moving Well for 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine Clinical & Translational Science Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Moving Well

Behavioral

Experimental arm

Staying Well

Behavioral

Active comparator arm

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in level of social support from baseline using the Lubben Social Network Scale-18 (LSNS-18)

    Time frame: Baseline, 6 months post-surgery

    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.

  2. Change in general health status from baseline using the 12-Item Short Form Survey (SF-12)

    Time frame: Baseline, 6 months post-surgery

    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.

  3. Change in level of pain catastrophizing from baseline using the Pain Catastrophizing Scale (PCS).

    Time frame: Baseline, 6 months post-surgery

    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.

  4. 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

    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.

  5. Change in level of self-efficacy from baseline using the General Self-Efficacy Scale (GSF)

    Time frame: Baseline, 6 months post-surgery

    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.

  6. Change in sleep disturbance from baseline using the Patient-Reported Outcomes Information System (PROMIS) Sleep Disturbance Scale.

    Time frame: Baseline, 6 months post-surgery

    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.

  7. Change in opioid use for knee pain from baseline using participant self-report

    Time frame: Baseline, 6 months post-surgery

    Self-reported use of opioids for knee pain

  8. Duration of post-surgery inpatient rehabilitation using the number of days of inpatient rehabilitation

    Time frame: 6 months post-surgery

    Self-reported duration of inpatient rehabilitation

  9. Change in knee range of motion from baseline using a goniometer

    Time frame: Baseline, 6 months post-surgery

    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.

  10. Change in Timed Up and Go test (TUG) from baseline

    Time frame: Baseline, 6 months post-surgery

    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.

  11. Change in 6-minute walk test (6MWT) from baseline

    Time frame: Baseline, 6 months post-surgery

    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.

  12. Change in 30-second chair to stand test from baseline

    Time frame: Baseline, 6 months post-surgery

    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.

  13. Change in quadriceps strength from baseline using a handheld dynamometer (HHD)

    Time frame: Baseline, 6 months post-surgery

    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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Hospital for Special Surgery, New York
  • Rheumatology Research Foundation

Registry information

Official study title

Moving Well Intervention for Patients Preparing to Undergo Total Knee Arthroplasty (TKA)

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 1, 2022
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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