N/A N=60 Randomized Single-blind Treatment

Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty

Knee Replacement, Total · Knee Arthroplasty, Total

Bottom Line

View on ClinicalTrials.gov: NCT04090125 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: Primary: Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer) — 0.59; 0.36 Minutes per week — p=0.485

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PAS Intervention (Behavioral); Attention Control (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer)	0.59; 0.36	0.485
PRIMARY Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)	0.12; 0.64	0.0887
PRIMARY Change From Baseline to Month 3 in Peak Joint Load Symmetry During Walking	0.04; -0.02	0.296
PRIMARY Change From Baseline to Month 6 in Peak Joint Load Symmetry During Walking	-0.05; 0.02	0.094
SECONDARY Change From Baseline to Month 3 in Self-Reported Physical Activity.	3.23; -0.62	0.11
SECONDARY Change From Baseline Month 6 in Self-Reported Physical Activity.	1.58; -0.16	0.55
SECONDARY Change From Baseline to Month 3 in Steps Per Day	0.18; 0.33	0.134
SECONDARY Change From Baseline to Month 6 in Steps Per Day	0.15; 0.32	0.09
SECONDARY Change From Baseline to Month 3 in Minutes of Any Physical Activity (PA)	0.04; 0.09	0.25
SECONDARY Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA)	0.00; 0.09	0.16
SECONDARY Change From Baseline to Month 3 in Sedentary Minutes	-5.32; -26.68	0.167
SECONDARY Change From Baseline to Month 6 in Sedentary Minutes	-1.37; -26.52	0.189
SECONDARY Change From Baseline to Month 3 in Berg Balance Scale	-4	—
SECONDARY Change From Baseline to Month 6 in Berg Balance Scale	—	—
SECONDARY Change From Baseline to Month 3 in Brief Balance Evaluation Systems Test	1	—
SECONDARY Change From Baseline to Month 6 in Brief Balance Evaluation Systems Test	—	—
SECONDARY Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS)	28.70; 26.19; 23.16; 22.02; 29.12; 32.66	0.42
SECONDARY Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS)	30.16; 28.72; 29.49; 25.54; 36.47; 34.83	0.65
SECONDARY Change From Baseline to Month 3 in Tampa Scale for Kinesiophobia	-4.81; -2.86	0.191
SECONDARY Change From Baseline to Month 6 in Tampa Scale for Kinesiophobia	-8.31; -2.86	0.0004 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04090125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.