Clinical trial NCT01537328: Progressive Rehabilitation Following Total Knee Arthroplasty
Official title: Progressive Rehabilitation Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Total knee arthroplasty
quadriceps
muscle
arthroplasty
joint diseases
musculoskeletal diseases
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-02-23
Enrollment: 185
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

* 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Stair climbing test (SCT)
timeFrame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Secondary outcomes:
measure: Change from baseline in Timed-up-and-go Test (TUG)
timeFrame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
measure: Change from baseline in 6-minute walk test (6MW)
timeFrame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
measure: Change from baseline in muscle strength
timeFrame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
measure: Change from baseline in self-reported health status
timeFrame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
measure: Change from baseline in muscle activation
timeFrame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer Stevens-Lapsley, MPT, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.