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Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty (PAS-TKA)

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ClinicalTrials.gov Identifier: NCT04090125
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Knee Replacement, Total Knee Arthroplasty, Total Behavioral: PAS Intervention Behavioral: Attention Control Not Applicable

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=72 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty
Actual Study Start Date : November 8, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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.
Behavioral: PAS Intervention
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.
Behavioral: Attention Control
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents MET ≥ 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity.

  2. 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. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents MET ≥ 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity.

  3. Change from Baseline to Month 3 in steps per day [ Time Frame: Baseline, Month 3 ]
    Step counts measured via accelerometer

  4. Change from Baseline to Month 6 in steps per day [ Time Frame: Baseline, Month 6 ]
    Step counts measured via accelerometer

  5. 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

  6. 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

  7. Change from Baseline to Month 3 in sedentary minutes [ Time Frame: Baseline, Month 3 ]
    Sedentary minutes measured via accelerometer

  8. Change from Baseline to Month 6 in sedentary minutes [ Time Frame: Baseline, Month 6 ]
    Sedentary minutes measured via accelerometer

  9. 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.

  10. 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.

  11. 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), total score = 24 points. Lower scores indicate higher levels of balance impairment.

  12. 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), total score = 24 points. Lower scores indicate higher levels of balance impairment.

  13. 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), 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.

  14. 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), 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.

  15. 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.

  16. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090125


Contacts
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Contact: Kelli D Allen, PhD 919-966-0558 kdallen@email.unc.edu
Contact: Kimberlea Grimm, MHS 919-843-9256 kimberlea_grimm@med.unc.edu

Locations
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United States, North Carolina
UNC Thurston Arthritis Research Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kelli D Allen, PhD    919-966-0558    kdallen@email.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Kelli D Allen, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04090125    
Other Study ID Numbers: 19-0568
R21AR074149-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data will become available following publication of primary and secondary outcomes, and data will be available until the study is closed with the local IRB.
Access Criteria: Data will be accessible following publication of study results and will be available until the study is closed with the local IRB.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
knee
total knee replacement
physical therapy