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Comparison of Treatments Following Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT02237911
Recruitment Status : Completed
First Posted : September 11, 2014
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Sara R. Piva, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 9, 2014
First Posted Date  ICMJE September 11, 2014
Results First Submitted Date  ICMJE December 31, 2017
Results First Posted Date  ICMJE March 11, 2019
Last Update Posted Date March 11, 2019
Study Start Date  ICMJE December 2014
Actual Primary Completion Date September 7, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF). [ Time Frame: Baseline, 3 and 6 months ]
WOMAC-PF is a patient reported outcome with 17 items. Each item is scored on a 5-point Likert-type Scale with descriptors from 0-4 (none, mild, moderate, severe, and extreme difficulty) and summed for a maximum score of 68. Higher scores indicate worse physical function.
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
Physical function assessed by patient reported questionnaire, the Western Ontario and McMaster Universities Osteoarthritis Index Physical Function Subscale (WOMAC-PF) [ Time Frame: up to 6 months ]
The WOMAC-PF consists of 17 items related to physical function. Each item is scored on a 5-point Likert-type Scale with descriptors from 0-4 (none, mild, moderate, severe, and extreme difficulty). Scores of each item are summed for a maximum total score on the WOMAC-PF of 68. Higher scores indicate worse functional limitations.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
Composite Score of Performed-based Tests of Physical Function. [ Time Frame: Baseline, 3 and 6 months ]
Scores on 6 performance-based tests (i.e., the 6-minute walk test, 40-meter gait speed, stair ascend/descend test, single leg stance balance test, chair stand test, and floor sitting-rising) were combined into a composite score formed with the unit-weighted Z scores of constituent tests to provide a more representative and stable measure of the subjects' underlying functional performance. The unit weights refer to averaging standardized scores (e.g., the scores for each performance-based test are converted to Z-scores before applying equal weights). Higher Z-scores represent better functional performance. The Z-scores for each participant can be interpreted as deviations from the baseline average of the whole group. We considered a change in Z-score of 0.2 as clinically important because it represents approximately 20% of a standard deviation relative to the baseline average of the whole group.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
Physical Activity assessed by a portable activity monitor, the SenseWear Minifly (SWM) [ Time Frame: 3 and 6 months ]
The SWM provides real-time measures of physical activity during normal activities of daily life.The SWM will be worn on the back of the right arm during 24 hours/7 days.
Current Other Pre-specified Outcome Measures
 (submitted: November 16, 2018)
Physical Activity Energy Expenditure - Measured by Portable Activity Monitor (SenseWear). [ Time Frame: Baseline, 3 and 6 months ]
Real-time measure of daily energy expenditure physical activity assessed by portable activity monitor.
Original Other Pre-specified Outcome Measures
 (submitted: September 10, 2014)
Performed-based physical function [ Time Frame: 3 and 6 months ]
Measured using tests germane to subjects after TKR and are easily performed in the clinical setting and include activities such as managing stair, ability to walk, endurance, balance and muscle strength.
 
Descriptive Information
Brief Title  ICMJE Comparison of Treatments Following Total Knee Replacement
Official Title  ICMJE A Comparison of Treatment Methods for Patients Following Total Knee Replacement.
Brief Summary Although total knee replacement (TKR) improves pain in numerous patients, it does not resolve many of the substantial functional limitations and physical inactivity that existed for a long time prior to the surgery. Exercise is an intervention that could improve these long-term limitations. To promote these improvements, exercise should be implemented at later stage post TKR when patients can tolerate doses of exercise sufficiently high to promote substantial changes. To date, we just don't have enough good research to tell us which type of exercise works best for which patients and under which circumstances at later stage post TKR. This research study will provide evidence for recommended interventions during the later stage post TKR. The specific research questions are: (1) How do group exercise in the community and individual exercise in rehabilitation clinic compare with usual medical care on physical function and activity outcomes? (2) Who are the patients most likely to respond to each exercise intervention? (3) Are the approaches safe?
Detailed Description This is a comparative effectiveness study, designed as a 3-group single-blind randomized clinical trial. Two hundred forty older adults who underwent TKR at least 2 months prior and are otherwise eligible will be randomized into one of three treatment approaches: 1) clinic-based individual outpatient rehabilitative exercise; 2) community-based group exercise classes; or 3) usual medical care. Subjects will be treated for 3 months. Data will be collected before intervention, after intervention (3 months), and 6 months after randomization. Physical function is a primary outcome and will be assessed by the Western Ontario and McMaster Universities Arthritis Index and a battery of performance-based tests germane to patients post TKR that includes ability to walk, manage stairs, lift from the floor and the chair, and one-leg balance. We will also use an accelerometer-based monitor that provides a real-time measure of physical activity during normal daily living and is able to accurately capture most levels of activity. Linear mixed models will be fitted to compare the changes in outcome across groups. Logistic regression will identify patient characteristics that predict functional recovery in the exercise groups. Survival analysis and instrumental variable methods will be used to compare attrition, adherence and adverse events between groups.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Degeneration; Articular Cartilage, Knee
  • Rheumatoid Arthritis
  • Osteoarthritis, Knee
Intervention  ICMJE
  • Other: Clinic-based outpatient exercise group
    Subjects will participate in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session will last about 60 minutes. Treatment sessions will utilize a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
  • Other: Community-based exercise group
    Subjects will attend to exercise classes (community-based) 2 times per week during 3 months. The exercise classes last approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
Study Arms  ICMJE
  • Experimental: Clinic-based outpatient exercise group
    Subjects will participate in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session will last about 60 minutes. Treatment sessions will utilize a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
    Intervention: Other: Clinic-based outpatient exercise group
  • Active Comparator: Community-based exercise group
    Subjects will attend to exercise classes (community-based) 2 times per week during 3 months. The exercise classes last approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
    Intervention: Other: Community-based exercise group
  • No Intervention: Wait-listed usual medical care
    Wait-listed usual medical care - no intervention provided by study.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2014)
240
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 7, 2017
Actual Primary Completion Date September 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Unilateral TKR 2 to 4 months prior
  • Older than 60 years of age
  • Experience functional limitation in daily activities (score in WOMAC-PF of at least 9 points)
  • Speak sufficient English to understand study instructions
  • Have medical clearance to participate in the study
  • Are willing to be randomized to one of the 3 treatment arms

Exclusion Criteria:

  • Have absolute or relative contraindications to exercise
  • Have history of uncontrolled cardiovascular disease or hypertension
  • Are unable to walk 50 meters without an assistive device
  • Have history of muscular or neurological disorder that affect lower extremity function
  • Regular participation in exercise
  • Terminal illness
  • Planning to have another joint replacement during the next 12 months
  • Plan not to be around during the next 12 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02237911
Other Study ID Numbers  ICMJE PRO14080261
CER-1310-06994 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sara R. Piva, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Sara R Piva, PT, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP