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
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Condition or disease | Intervention/treatment | Phase |
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Degeneration; Articular Cartilage, Knee Rheumatoid Arthritis Osteoarthritis, Knee | Other: Clinic-based outpatient exercise group Other: Community-based exercise group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Study Completion Date : | September 7, 2017 |

Arm | Intervention/treatment |
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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.
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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.
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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: Wait-listed usual medical care
Wait-listed usual medical care - no intervention provided by study.
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- 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.
- 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.
- 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.

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

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
United States, Pennsylvania | |
Department of Physical Therapy, University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15219 |
Principal Investigator: | Sara R Piva, PT, PhD | University of Pittsburgh |
Documents provided by Sara R. Piva, University of Pittsburgh:
Responsible Party: | Sara R. Piva, Dr., University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT02237911 |
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 |
Results First Posted: | March 11, 2019 |
Last Update Posted: | March 11, 2019 |
Last Verified: | November 2018 |
total knee replacement rehabilitation exercise program total knee arthroplasty |
Osteoarthritis, Knee Arthritis Joint Diseases |
Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases |