KArAT (Knee Arthroplasty Activity Trial): Rationale and design features of a multicenter randomized controlled trial

Background: Total knee arthroplasty (TKA) is commonly performed to relieve pain in persons with severe knee osteoarthritis. Despite substantial pain reduction and functional improvements, physical activity (PA) does not necessarily increase post TKA. The premise for this randomized trial is that a b...

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Main Authors: Elena Losina, Jamie E. Collins, Mahima Kumara, Linda Ehrlich-Jones, Maame Opare-Addo, Clare Safran-Norton, Neil A. Segal, Lauren M. Mitchell, Paul T. Kopp, Faith Selzer, Hanna Mass, Michael Paskewicz, Rowland W. Chang, Dorothy Dunlop, Antonia F. Chen, Samuel Lerner, Samantha Chin, Christine Pellegrini, Jeffrey N. Katz
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:Osteoarthritis and Cartilage Open
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Online Access:http://www.sciencedirect.com/science/article/pii/S2665913124000797
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author Elena Losina
Jamie E. Collins
Mahima Kumara
Linda Ehrlich-Jones
Maame Opare-Addo
Clare Safran-Norton
Neil A. Segal
Lauren M. Mitchell
Paul T. Kopp
Faith Selzer
Hanna Mass
Michael Paskewicz
Rowland W. Chang
Dorothy Dunlop
Antonia F. Chen
Samuel Lerner
Samantha Chin
Christine Pellegrini
Jeffrey N. Katz
author_facet Elena Losina
Jamie E. Collins
Mahima Kumara
Linda Ehrlich-Jones
Maame Opare-Addo
Clare Safran-Norton
Neil A. Segal
Lauren M. Mitchell
Paul T. Kopp
Faith Selzer
Hanna Mass
Michael Paskewicz
Rowland W. Chang
Dorothy Dunlop
Antonia F. Chen
Samuel Lerner
Samantha Chin
Christine Pellegrini
Jeffrey N. Katz
author_sort Elena Losina
collection DOAJ
description Background: Total knee arthroplasty (TKA) is commonly performed to relieve pain in persons with severe knee osteoarthritis. Despite substantial pain reduction and functional improvements, physical activity (PA) does not necessarily increase post TKA. The premise for this randomized trial is that a behavioral intervention invoking internal and external motivators could lead to improvement in PA uptake post TKA. Methods: KArAT (the Knee Arthroplasty Activity Trial) is a three-arm multi-center randomized controlled trial designed to establish the efficacy and sustainability of a personalized behavioral intervention in improving PA among TKA recipients with a primary diagnosis of knee osteoarthritis. The three arms include: 1) usual care, 2) attention control with Fitbit activity trackers, and 3) health coaching and financial incentives for reaching personalized PA goals. The primary outcome is defined as the proportion of participants engaged in at least 150 ​min of moderate-to-vigorous physical activity over a given week after the 6-month intervention. We also plan to conduct a cost-effectiveness analysis to establish the value and affordability of the KArAT interventions. Discussion: This paper aims to outline the rationale, study design, and implementation of KArAT. Trial Registration: Clinicaltrials.gov NCT04107649.
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spelling doaj-art-2b92ceee168249739585e537a763516d2025-08-20T01:55:21ZengElsevierOsteoarthritis and Cartilage Open2665-91312025-06-017210051210.1016/j.ocarto.2024.100512KArAT (Knee Arthroplasty Activity Trial): Rationale and design features of a multicenter randomized controlled trialElena Losina0Jamie E. Collins1Mahima Kumara2Linda Ehrlich-Jones3Maame Opare-Addo4Clare Safran-Norton5Neil A. Segal6Lauren M. Mitchell7Paul T. Kopp8Faith Selzer9Hanna Mass10Michael Paskewicz11Rowland W. Chang12Dorothy Dunlop13Antonia F. Chen14Samuel Lerner15Samantha Chin16Christine Pellegrini17Jeffrey N. Katz18Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA; Corresponding author. Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, 60 Fenwood Rd, Suite 5016, Boston, MA 02115, USA.Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USAOrthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USAShirley Ryan AbilityLab, Chicago, IL, USA; Departments of Preventive Medicine, Medicine, and Physical Medicine & Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, IL, USAOrthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USADepartment of Rehabilitation Services, Physical Therapy, Brigham and Women's Hospital, Boston, MA, USADepartment of Physical Medicine and Rehabilitation, University of Kansas Medical Center, USAOrthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USAOrthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USAOrthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USAOrthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USAOrthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USADepartments of Preventive Medicine, Medicine, and Physical Medicine & Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, IL, USADepartments of Preventive Medicine, Medicine, and Physical Medicine & Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, IL, USAHarvard Medical School, Boston, MA, USA; Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USAOrthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USAOrthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USADepartment of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, USAOrthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, USA; Departments of Epidemiology and Environmental Health, Harvard T. H. Chan School of Public Health, Boston, MA, USABackground: Total knee arthroplasty (TKA) is commonly performed to relieve pain in persons with severe knee osteoarthritis. Despite substantial pain reduction and functional improvements, physical activity (PA) does not necessarily increase post TKA. The premise for this randomized trial is that a behavioral intervention invoking internal and external motivators could lead to improvement in PA uptake post TKA. Methods: KArAT (the Knee Arthroplasty Activity Trial) is a three-arm multi-center randomized controlled trial designed to establish the efficacy and sustainability of a personalized behavioral intervention in improving PA among TKA recipients with a primary diagnosis of knee osteoarthritis. The three arms include: 1) usual care, 2) attention control with Fitbit activity trackers, and 3) health coaching and financial incentives for reaching personalized PA goals. The primary outcome is defined as the proportion of participants engaged in at least 150 ​min of moderate-to-vigorous physical activity over a given week after the 6-month intervention. We also plan to conduct a cost-effectiveness analysis to establish the value and affordability of the KArAT interventions. Discussion: This paper aims to outline the rationale, study design, and implementation of KArAT. Trial Registration: Clinicaltrials.gov NCT04107649.http://www.sciencedirect.com/science/article/pii/S2665913124000797Total knee arthroplastyPhysical activityBehavioral economicsClinical trial
spellingShingle Elena Losina
Jamie E. Collins
Mahima Kumara
Linda Ehrlich-Jones
Maame Opare-Addo
Clare Safran-Norton
Neil A. Segal
Lauren M. Mitchell
Paul T. Kopp
Faith Selzer
Hanna Mass
Michael Paskewicz
Rowland W. Chang
Dorothy Dunlop
Antonia F. Chen
Samuel Lerner
Samantha Chin
Christine Pellegrini
Jeffrey N. Katz
KArAT (Knee Arthroplasty Activity Trial): Rationale and design features of a multicenter randomized controlled trial
Osteoarthritis and Cartilage Open
Total knee arthroplasty
Physical activity
Behavioral economics
Clinical trial
title KArAT (Knee Arthroplasty Activity Trial): Rationale and design features of a multicenter randomized controlled trial
title_full KArAT (Knee Arthroplasty Activity Trial): Rationale and design features of a multicenter randomized controlled trial
title_fullStr KArAT (Knee Arthroplasty Activity Trial): Rationale and design features of a multicenter randomized controlled trial
title_full_unstemmed KArAT (Knee Arthroplasty Activity Trial): Rationale and design features of a multicenter randomized controlled trial
title_short KArAT (Knee Arthroplasty Activity Trial): Rationale and design features of a multicenter randomized controlled trial
title_sort karat knee arthroplasty activity trial rationale and design features of a multicenter randomized controlled trial
topic Total knee arthroplasty
Physical activity
Behavioral economics
Clinical trial
url http://www.sciencedirect.com/science/article/pii/S2665913124000797
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