- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04090125
Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty (PAS-TKA)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- UNC Thurston Arthritis Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical Activity and Symmetry (PAS) Intervention
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
|
The PAS program will be initiated during the final usual care PT visits.
The PAS content will be included within the last two routine PT visits (Sessions 1 and 2).
Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA.
Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned.
Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
|
Placebo Comparator: Attention Control
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
|
This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist.
Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional.
Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer)
Time Frame: Baseline, Month 3
|
Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
Baseline, Month 3
|
Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)
Time Frame: Baseline, Month 6
|
Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
Baseline, Month 6
|
Change From Baseline to Month 3 in Peak Joint Load Symmetry During Walking
Time Frame: Baseline, Month 3
|
Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (|Surgical/Non-Surgical|*100), values lower than 100% indicate less loading of the surgical limb. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
Baseline, Month 3
|
Change From Baseline to Month 6 in Peak Joint Load Symmetry During Walking
Time Frame: Baseline, Month 6
|
Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (|Surgical/Non-Surgical|*100), values lower than 100% indicate less loading of the surgical limb. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
Baseline, Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to Month 3 in Self-Reported Physical Activity.
Time Frame: Baseline, Month 3
|
Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure.
Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity.
This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents ≥ 3.0).
A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
|
Baseline, Month 3
|
Change From Baseline Month 6 in Self-Reported Physical Activity.
Time Frame: Baseline to Month 6
|
Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure.
Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity.
This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents ≥ 3.0).
A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
|
Baseline to Month 6
|
Change From Baseline to Month 3 in Steps Per Day
Time Frame: Baseline, Month 3
|
Step counts measured via accelerometer.
A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
|
Baseline, Month 3
|
Change From Baseline to Month 6 in Steps Per Day
Time Frame: Baseline, Month 6
|
Step counts measured via accelerometer.
A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
|
Baseline, Month 6
|
Change From Baseline to Month 3 in Minutes of Any Physical Activity (PA)
Time Frame: Baseline, Month 3
|
Minutes of any PA measured via accelerometer.
A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
|
Baseline, Month 3
|
Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA)
Time Frame: Baseline, Month 6
|
Minutes of any PA measured via accelerometer.
A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
|
Baseline, Month 6
|
Change From Baseline to Month 3 in Sedentary Minutes
Time Frame: Baseline, Month 3
|
Minutes of sedentary activity per day, measured via accelerometer
|
Baseline, Month 3
|
Change From Baseline to Month 6 in Sedentary Minutes
Time Frame: Baseline, Month 6
|
Minutes of sedentary activity per day, measured via accelerometer
|
Baseline, Month 6
|
Change From Baseline to Month 3 in Berg Balance Scale
Time Frame: Baseline, Month 3
|
Berg Balance Scale includes 14 tests of static and dynamic balance.
Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function.
The total score ranges from 0 to 56.
Lower scores indicate reduced functional mobility.
|
Baseline, Month 3
|
Change From Baseline to Month 6 in Berg Balance Scale
Time Frame: Baseline, Month 6
|
Berg Balance Scale includes 14 tests of static and dynamic balance.
Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function.
The total score ranges from 0 to 56.
Lower scores indicate reduced functional mobility.
|
Baseline, Month 6
|
Change From Baseline to Month 3 in Brief Balance Evaluation Systems Test
Time Frame: Baseline, Month 3
|
Brief Balance Evaluation Systems includes 8 tasks across 6 domains.
Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24).
Lower scores indicate higher levels of balance impairment.
|
Baseline, Month 3
|
Change From Baseline to Month 6 in Brief Balance Evaluation Systems Test
Time Frame: Baseline, Month 6
|
Brief Balance Evaluation Systems includes 8 tasks across 6 domains.
Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24.
Lower scores indicate higher levels of balance impairment.
|
Baseline, Month 6
|
Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline, Month 3
|
The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems.
Five KOOS subscale scores were administered: Pain (9 items), Symptoms (7 items), Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items).
All items are scored on 5-point Likert scales.
A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
|
Baseline, Month 3
|
Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline, Month 6
|
The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems.
Five KOOS subscale scores were administered: Pain (9 items), Symptoms (7 it4ems) Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items).
All items are scored on 5-point Likert scales.
A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
|
Baseline, Month 6
|
Change From Baseline to Month 3 in Tampa Scale for Kinesiophobia
Time Frame: Baseline, Month 3
|
The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement.
The scale specifically assesses activity avoidance due to pain-related fear of movement.
All items are measured on a 4-point scale from "strongly agree" to "strongly disagree."
A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible.
A score of 68 is the highest possible score and indicates extreme fear of pain with movement.
|
Baseline, Month 3
|
Change From Baseline to Month 6 in Tampa Scale for Kinesiophobia
Time Frame: Baseline, Month 6
|
The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement.
The scale specifically assesses activity avoidance due to pain-related fear of movement.
All items are measured on a 4-point scale from "strongly agree" to "strongly disagree."
A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible.
A score of 68 is the highest possible score and indicates extreme fear of pain with movement.
|
Baseline, Month 6
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kelli D Allen, PhD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19-0568
- R21AR074149-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Arthroplasty, Total
-
Limacorporate S.p.aRecruitingTotal Knee Arthroplasty | Revision Total Knee ArthroplastyUnited Kingdom, Portugal, Slovakia
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
-
Northern Orthopaedic Division, DenmarkCompletedTotal Knee Arthroplasty | Total Hip ArthroplastyDenmark
-
Singapore General HospitalCompletedTotal Knee Arthroplasty | Total Knee ReplacementSingapore
-
Istanbul UniversityCompleted
-
Istanbul UniversityCompletedTotal Knee Arthroplasty | Total Knee ReplacementTurkey
-
Smith & Nephew, Inc.Completed
-
University of AlbertaCompletedArthroplasty, Replacement, Knee | Knee Arthroplasty, TotalCanada
-
James A. KeeneyRecruitingPrimary Total Hip Arthroplasty | Primary Total Knee ArthroplastyUnited States
Clinical Trials on PAS Intervention
-
Binghamton UniversityLehigh University; Ascension HealthNot yet recruitingObesity | Physical Activity | Self-efficacy | Online Intervention | Accelerometers
-
Burke Medical Research InstituteTerminated
-
VA Office of Research and DevelopmentCompleted
-
NeurolignUniversity of Miami; Allegheny Singer Research Institute (also known as Allegheny...Not yet recruiting
-
University of MiamiCompleted
-
Institut National de la Santé Et de la Recherche...UnknownStroke and Healthy SubjectsFrance
-
University of ZurichFreie Universität BerlinTerminatedPsychological DistressSwitzerland, Germany
-
University of MiamiSyneos Health; NeurolignWithdrawnBrain Injuries, Traumatic
-
University of MiamiNeurolignRecruitingBrain Injuries | Brain Injuries, Traumatic | Traumatic Brain Injury | Mild Traumatic Brain Injury | Head InjuryUnited States