Comparison of Treatments Following Total Knee Replacement
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 3/13/2019 |
| Start Date: | December 2014 |
| End Date: | September 7, 2017 |
A Comparison of Treatment Methods for Patients Following Total Knee Replacement.
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?
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?
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.
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.
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
We found this trial at
1
site
Pittsburgh, Pennsylvania 15219
Phone: 412-383-6762
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