Moving Well for Total Knee Arthroplasty (TKA)

NCT ID: NCT05217420

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-05

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Only research team members who will collect objective in-person data will be masked

Study Groups

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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.

Group Type EXPERIMENTAL

Moving Well

Intervention Type BEHAVIORAL

Experimental arm

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.

Group Type ACTIVE_COMPARATOR

Staying Well

Intervention Type BEHAVIORAL

Active comparator arm

Interventions

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Moving Well

Experimental arm

Intervention Type BEHAVIORAL

Staying Well

Active comparator arm

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rheumatology Research Foundation

OTHER

Sponsor Role collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Iris Y Navarro Millan, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medicine Clinical & Translational Science Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37147587 (View on PubMed)

Other Identifiers

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19-08020638

Identifier Type: -

Identifier Source: org_study_id

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