Progressive Rehabilitation Following Total Knee Arthroplasty

Study Overview
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Brief Summary
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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: PROG will result in greater improvements in functional outcome measures such as: stair climbing test (SCT), timed-up-and-go test (TUG), six minute walk test (6MW), the Knee Injury and Osteoarthritis Outcome Survey (WOMAC), and knee range of motion (ROM). PROG will result in greater improvements in quadriceps muscle strength gains after TKA compared to TRAD. PROG will result in greater improvements in muscle mass and central activation compared to TRAD.

Detailed Description
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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.

Official Title
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Progressive Rehabilitation Following Total Knee Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: Total knee replacement rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing a primary, unilateral knee arthroplasty body mass index < 40 kg/m2 Exclusion Criteria: severe contralateral leg OA (< 5/10 pain with stair climbing) or other unstable orthopaedic conditions that limit function neurological conditions that affect muscle function vascular or cardiac problems that limit function uncontrolled diabetes pregnancy

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progressive Treatment<br>Progressive intervention will involve the early initiation of intensive rehabilitation using progressive exercise and faster progression to functional strengthening exercises. | Other: Total knee replacement rehabilitation<br>* 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.<br>|
| Active Comparator: Traditional treatment<br>Traditional intervention represents the synthesis of previously published total knee arthroplasty rehabilitation programs. | Other: Total knee replacement rehabilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, quadriceps, muscle, arthroplasty, joint diseases, musculoskeletal diseases