Moving Well for Total Knee Arthroplasty (TKA)

July 30, 2026 updated by: Weill Medical College of Cornell University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine Clinical & Translational Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Moving Well
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.
Behavioral: Moving Well
Experimental arm
Active Comparator: Staying Well
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.
Behavioral: Staying Well
Active comparator arm

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 months post-surgery
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.
Baseline, 6 months post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
Self-reported use of opioids for knee pain
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
Self-reported duration of inpatient rehabilitation
6 months post-surgery
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.
Baseline, 6 months post-surgery
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.
Baseline, 6 months post-surgery
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.
Baseline, 6 months post-surgery
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.
Baseline, 6 months post-surgery
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.
Baseline, 6 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital for Special Surgery, New York
Rheumatology Research Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Iris Y Navarro Millan, MD, MSPH, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-08020638

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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