Progressive Rehabilitation Following Total Knee Arthroplasty (PROG)
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| First Received Date ICMJE | August 26, 2011 | ||||||||
| Last Updated Date | January 4, 2013 | ||||||||
| Start Date ICMJE | July 2011 | ||||||||
| Estimated Primary Completion Date | May 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change from baseline in Stair climbing test (SCT) [ Time Frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months ] [ Designated as safety issue: No ] Time to ascend and descend one flight of stairs |
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| Original Primary Outcome Measures ICMJE |
Change from baseline in Stair climbing test (SCT) [ Time Frame: pre operatively (average of two weeks before surgery), post operatively at 1, 2, 3 (primary endpoint), 6 and 12 months ] [ Designated as safety issue: No ] Time to ascend and descend one flight of stairs |
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| Change History | Complete list of historical versions of study NCT01537328 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Progressive Rehabilitation Following Total Knee Arthroplasty | ||||||||
| Official Title ICMJE | Progressive Rehabilitation Following Total Knee Arthroplasty | ||||||||
| Brief Summary | 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:
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| Detailed Description | 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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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Osteoarthritis | ||||||||
| Intervention ICMJE | Other: Total knee replacement rehabilitation
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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 162 | ||||||||
| Estimated Completion Date | May 2017 | ||||||||
| Estimated Primary Completion Date | May 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 50 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01537328 | ||||||||
| Other Study ID Numbers ICMJE | 10-1188, R01HD065900 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University of Colorado, Denver | ||||||||
| Study Sponsor ICMJE | University of Colorado, Denver | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Colorado, Denver | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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