Clinical trial NCT04090125: Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty
Official title: Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Replacement, Total
Knee Arthroplasty, Total
Keywords: knee
total knee replacement
physical therapy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2019-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to examine the effectiveness of the Physical Activity and Symmetry (PAS) program, compared to an attention (ATT)control group, for patients with post-total knee arthroplasty (TKA). The investigators hypothesize that the PAS treatment will result in meaningful improvements in physical activity (PA) and joint loading symmetry compared to the ATT group.

Detailed description: Background and Significance: Total knee arthroplasty (TKA) has been shown to decrease pain and to improve range of motion and some aspects of physical function. However, accumulating evidence shows that patients have persistent deficits in other critical outcomes following TKA. First, the majority of patients do not substantially increase physical activity beyond levels prior to TKA, remaining well below Department of Health and Human Services recommendations and levels of healthy individuals. This has serious negative implications for both joint health and overall health. Second, studies show that gait asymmetries are common following TKA, such that patients continue to load the non-surgical leg more heavily during walking, even when the post-surgical leg is pain free. This places the contralateral limb at risk for developing or worsening osteoarthritis. Other research shows there is large variability in post-TKA rehabilitation, along with sub-optimal exercise content. Collectively, these findings emphasize the critical need to improve the post-TKA rehabilitation process. However, there are currently no evidence-based approaches to improve overall physical activity and deficits in joint loading symmetry that have been identified following TKA.

Study Aims: This research project will provide important preliminary information on the novel post-TKA PAS program through achieving the following specific aims: 1) Obtain preliminary data on the efficacy of the PAS program with respect to the change in objectively assessed physical activity, measured via accelerometers; 2) Obtain preliminary data on the efficacy of the PAS program with respect to change in peak load symmetry during walking, measured by a novel 3-sensor insole device; 3) Assess the feasibility and acceptability of the PAS program following TKA.

Study Description: Investigators will conduct an exploratory randomized controlled study, with n=60 patients \>=18 years receiving post-TKA physical therapy (PT) at a UNC Healthcare System clinic. Patients will be equally allocated to the PAS intervention or an attention (ATT) control group.

Eligibility criteria: Inclusion Criteria:

* Patients receiving post-total knee arthroplasty (TKA) physical therapy (PT) at a University of North Carolina (UNC) Healthcare System clinic

Exclusion Criteria:

* significant cognitive impairment
* neurological disorders affecting gait
* systemic rheumatic disease
* hospitalization for a cardiovascular condition the past six months
* psychosis
* substance abuse disorder
* lower extremity surgery in the past year
* any other health conditions determined to be contraindications to a home exercise program

Primary outcomes:
measure: Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer)
timeFrame: Baseline, Month 3
measure: Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)
timeFrame: Baseline, Month 6
measure: Change From Baseline to Month 3 in Peak Joint Load Symmetry During Walking
timeFrame: Baseline, Month 3
measure: Change From Baseline to Month 6 in Peak Joint Load Symmetry During Walking
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change From Baseline to Month 3 in Self-Reported Physical Activity.
timeFrame: Baseline, Month 3
measure: Change From Baseline Month 6 in Self-Reported Physical Activity.
timeFrame: Baseline to Month 6
measure: Change From Baseline to Month 3 in Steps Per Day
timeFrame: Baseline, Month 3
measure: Change From Baseline to Month 6 in Steps Per Day
timeFrame: Baseline, Month 6
measure: Change From Baseline to Month 3 in Minutes of Any Physical Activity (PA)
timeFrame: Baseline, Month 3
measure: Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA)
timeFrame: Baseline, Month 6
measure: Change From Baseline to Month 3 in Sedentary Minutes
timeFrame: Baseline, Month 3
measure: Change From Baseline to Month 6 in Sedentary Minutes
timeFrame: Baseline, Month 6
measure: Change From Baseline to Month 3 in Berg Balance Scale
timeFrame: Baseline, Month 3
measure: Change From Baseline to Month 6 in Berg Balance Scale
timeFrame: Baseline, Month 6
measure: Change From Baseline to Month 3 in Brief Balance Evaluation Systems Test
timeFrame: Baseline, Month 3
measure: Change From Baseline to Month 6 in Brief Balance Evaluation Systems Test
timeFrame: Baseline, Month 6
measure: Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, Month 3
measure: Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, Month 6
measure: Change From Baseline to Month 3 in Tampa Scale for Kinesiophobia
timeFrame: Baseline, Month 3
measure: Change From Baseline to Month 6 in Tampa Scale for Kinesiophobia
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Thurston Arthritis Research Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kelli D Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References: