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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD065900 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this study is to evaluate the effectiveness of a progressive resistance rehabilitation program (PROG) after total knee arthroplasty (TKA) compared to a traditional rehabilitation program (TRAD).
The investigators hypothesized:
Over 500,000 total knee arthroplasties (TKAs) are performed each year in the United States to alleviate pain and disability associated with knee osteoarthritis (OA), and this number is expected to grow to 3.48 million per year by the year 2030. TKA reduces pain and improves self-reported function compared to pre-operative levels, but post-operative deficits in walking speed (20% slower) and stair climbing speed (50% slower) can persist for years. Stair climbing performance is the single largest residual deficit after TKA with seventy-five percent of TKA patients reporting difficulty negotiating stairs after surgery. Collectively, these findings suggest that current rehabilitation does not adequately target the impairments that lead to long-term deficits in functional mobility after TKA.
The aim of the proposed trial is to evaluate the effectiveness of a progressive resistance rehabilitation program (PROG) after TKA compared to a traditional rehabilitation program (TRAD). The PROG intervention will involve intensive rehabilitation using progressive resistance exercise and faster progression to functional strengthening exercises. The TRAD intervention represents the synthesis of previously published TKA rehabilitation programs. Our preliminary data suggest that the PROG intervention has low risk and results in improved functional mobility and muscle strength. The investigators will measure function and strength at six time points (pre-op; 1, 2, 3, 6, and 12 months after TKA). The investigators will also evaluate the contribution of changes in muscle mass (atrophy/hypertrophy) and central activation to changes in muscle strength following PROG and TRAD interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progressive Treatment | Experimental | Progressive intervention will involve the early initiation of intensive rehabilitation using progressive exercise and faster progression to functional strengthening exercises. |
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| Traditional treatment | Active Comparator | Traditional intervention represents the synthesis of previously published total knee arthroplasty rehabilitation programs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee replacement rehabilitation | Other | After total knee arthroplasty, patients will be assigned to an outpatient rehabilitation clinic, based upon geography. Patients will be enrolled randomly into one of two rehabilitation programs (PROG or TRAD). Both rehabilitation programs will take place over 12 weeks. Both groups will receive treatment for range of motion, activities of daily living and gait training, as well as a home exercise program. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Stair climbing test (SCT) | Time to ascend and descend one flight of stairs | pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Timed-up-and-go Test (TUG) | pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months | |
| Change from baseline in 6-minute walk test (6MW) | pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Stevens-Lapsley, MPT, PHD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28864244 | Derived | Bade M, Struessel T, Paxton R, Winters J, Baym C, Stevens-Lapsley J. Performance on a Clinical Quadriceps Activation Battery Is Related to a Laboratory Measure of Activation and Recovery After Total Knee Arthroplasty. Arch Phys Med Rehabil. 2018 Jan;99(1):99-106. doi: 10.1016/j.apmr.2017.07.013. Epub 2017 Aug 31. | |
| 27813347 | Derived | Bade MJ, Struessel T, Dayton M, Foran J, Kim RH, Miner T, Wolfe P, Kohrt WM, Dennis D, Stevens-Lapsley JE. Early High-Intensity Versus Low-Intensity Rehabilitation After Total Knee Arthroplasty: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Sep;69(9):1360-1368. doi: 10.1002/acr.23139. Epub 2017 Aug 13. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
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| Change from baseline in muscle strength | Isometric quadriceps and hamstrings strength. | pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months |
| Change from baseline in self-reported health status | WOMAC and SF-12 | pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months |
| Change from baseline in muscle activation | Doublet interpolation for quadriceps activation. | pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months |