Moving Well for Total Knee Arthroplasty (TKA)

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05217420
• Other study ID #: 19-08020638
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Weill Medical College of Cornell University
• Contact: Vanessa Madrigal, BS
• Phone: 646-962-7875
• Email: vam4007[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Behavioral:
• Moving Well
Experimental arm
• Staying Well
Active comparator arm

Locations

Country	Name	City	State
United States	Weill Cornell Medicine Clinical & Translational Science Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Hospital for Special Surgery, New York, Rheumatology Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6 months post-surgery
Primary	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.	Baseline, 6 months post-surgery
Secondary	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.	Baseline, 6 months post-surgery
Secondary	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.	Baseline, 6 months post-surgery
Secondary	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.	Baseline, 6 months post-surgery
Secondary	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.	Baseline, 6 months post-surgery
Secondary	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.	Baseline, 6 months post-surgery
Secondary	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.	Baseline, 6 months post-surgery
Secondary	Change in opioid use for knee pain from baseline using participant self-report	Self-reported use of opioids for knee pain	Baseline, 6 months post-surgery
Secondary	Duration of post-surgery inpatient rehabilitation using the number of days of inpatient rehabilitation	Self-reported duration of inpatient rehabilitation	6 months post-surgery
Secondary	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.	Baseline, 6 months post-surgery
Secondary	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.	Baseline, 6 months post-surgery
Secondary	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.	Baseline, 6 months post-surgery
Secondary	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.	Baseline, 6 months post-surgery
Secondary	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.	Baseline, 6 months post-surgery