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Comparison of Treatments Following Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT02237911
Recruitment Status : Active, not recruiting
First Posted : September 11, 2014
Last Update Posted : October 4, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Sara R. Piva, University of Pittsburgh

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?

Condition or disease Intervention/treatment Phase
Degeneration; Articular Cartilage, Knee Rheumatoid Arthritis Osteoarthritis, Knee Other: Clinic-based outpatient exercise group Other: Community-based exercise group Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Treatment Methods for Patients Following Total Knee Replacement.
Study Start Date : December 2014
Actual Primary Completion Date : September 7, 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.

No Intervention: Waited-list usual medical care
Usual medical care



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02237911


Locations
United States, Pennsylvania
Department of Physical Therapy, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Sponsors and Collaborators
University of Pittsburgh
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Sara R Piva, PT, PhD University of Pittsburgh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sara R. Piva, Dr., University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02237911     History of Changes
Other Study ID Numbers: PRO14080261
CER-1310-06994 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: February 2017

Keywords provided by Sara R. Piva, University of Pittsburgh:
total knee replacement
rehabilitation
exercise program
total knee arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis, Rheumatoid
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases