N/A
N=240
Comparison of Treatments Following Total Knee Replacement
Degeneration; Articular Cartilage, Knee · Rheumatoid Arthritis · Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT02237911 ↗Enrolled (actual)
240
Serious AEs
5.8%
Results posted
Mar 2019
Primary outcome: Primary: The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF). — 20.9; 20.4; 20.2; 10.1 units on a scale — p=0.071
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clinic-based outpatient exercise group (Other); Community-based exercise group (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF). |
20.9; 20.4; 20.2; 10.1; 12.2; 11.9 | 0.071 |
| SECONDARY Composite Score of Performed-based Tests of Physical Function. |
0.02; -0.06; -0.11; 0.49; 0.3; 0.13 | <0.0001 sig |
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?
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02237911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.