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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG029978-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| American College of Rheumatology Research and Education Foundation | OTHER |
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The purpose of this study is to determine whether early intervention with neuromuscular electrical stimulation (NMES) for muscle strengthening immediately after total knee arthroplasty (TKA) is more effective than voluntary exercise alone in countering changes in quadriceps muscle activation, force production, and function in older adults.
Osteoarthritis (OA) is a chronic degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. To alleviate pain and disability associated with knee OA, over 400,000 total knee arthroplasty (TKA) are performed each year in the United States, and future projections indicate that by the year 2030, more than 750,000 TKAs will be performed per year. While TKA reliably reduces pain and improves function, the recovery of force and function to normal levels is rare, which predisposes patients to future disability with increasing age. A month after TKA, impairments in quadriceps force are predominantly due to reflex inhibition, but are also influenced, to a lesser degree, by muscle atrophy. Neuromuscular electrical stimulation (NMES) may offer a promising alternative approach to override quadriceps reflex inhibition and prevent muscle atrophy to restore normal quadriceps muscle function more effectively than voluntary exercise alone, especially when applied within the first days after surgery.
The overall goal of this study is to evaluate the efficacy of NMES initiated 48hrs after TKA as an adjunct to standard rehabilitation. NMES is expected to more effectively restore normal quadriceps muscle function to produce greater quadriceps force by decreasing reflex inhibition. Patients will be randomized into one of two rehabilitation groups: 1) the standard rehabilitation group or 2) standard rehabilitation + NMES.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) | Experimental |
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| Standard Rehabilitation Protocol | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) | Device | NMES 20 minutes twice a day for 6 weeks plus standard physical therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively | A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion. | Baseline through 3.5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively | A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion. | Baseline through 1 year |
| Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Stevens, MPT, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCD Physical Therapy Program | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17710905 | Background | Mintken PE, Carpenter KJ, Eckhoff D, Kohrt WM, Stevens JE. Early neuromuscular electrical stimulation to optimize quadriceps muscle function following total knee arthroplasty: a case report. J Orthop Sports Phys Ther. 2007 Jul;37(7):364-71. doi: 10.2519/jospt.2007.2541. | |
| 15866968 | Background | Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992. |
| Label | URL |
|---|---|
| University of Colorado at Denver Muscle Performance Laboratory | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neuromuscular Electrical Stimulation (NMES) | Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy |
| FG001 | Standard Rehabilitation Protocol (Control) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Standard Rehabilitation Protocol | Other | Standard physical therapy for 8 weeks after surgery |
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The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval. |
| 3.5 weeks post-operatively |
| Functional Performance Measure: Timed "Up & Go" Test [TUG] at 3.5 Weeks Post-operatively | The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance. | 3.5 weeks post-operatively |
| Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively | The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs. | 3.5 weeks post-operatively |
| Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively | The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval. | 1 year post-operatively |
| Functional Performance Measure: Timed "Up & Go" Test [TUG] at 1 Year Post-operatively | The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance. | 1 year post-operatively |
| Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively | The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs. | 1 year post-operatively |
| 16078331 | Background | Mizner RL, Petterson SC, Stevens JE, Axe MJ, Snyder-Mackler L. Preoperative quadriceps strength predicts functional ability one year after total knee arthroplasty. J Rheumatol. 2005 Aug;32(8):1533-9. |
| 22652985 | Derived | Stevens-Lapsley JE, Balter JE, Wolfe P, Eckhoff DG, Schwartz RS, Schenkman M, Kohrt WM. Relationship between intensity of quadriceps muscle neuromuscular electrical stimulation and strength recovery after total knee arthroplasty. Phys Ther. 2012 Sep;92(9):1187-96. doi: 10.2522/ptj.20110479. Epub 2012 May 31. |
| 22095207 | Derived | Stevens-Lapsley JE, Balter JE, Wolfe P, Eckhoff DG, Kohrt WM. Early neuromuscular electrical stimulation to improve quadriceps muscle strength after total knee arthroplasty: a randomized controlled trial. Phys Ther. 2012 Feb;92(2):210-26. doi: 10.2522/ptj.20110124. Epub 2011 Nov 17. |
Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
| 3.5 Weeks Post-operatively |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Neuromuscular Electrical Stimulation (NMES) | Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy |
| BG001 | Standard Rehabilitation Protocol (Control) | Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively | A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion. | The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability. | Posted | Mean | Standard Error | change in N-m/kg | Baseline through 3.5 weeks |
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| Secondary | Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively | A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion. | The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability. | Posted | Mean | Standard Deviation | change in N-m/kg | Baseline through 1 year |
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| Secondary | Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively | The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval. | The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability. | Posted | Mean | Standard Deviation | meters | 3.5 weeks post-operatively |
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| Secondary | Functional Performance Measure: Timed "Up & Go" Test [TUG] at 3.5 Weeks Post-operatively | The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance. | The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability. | Posted | Mean | Standard Deviation | seconds | 3.5 weeks post-operatively |
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| Secondary | Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively | The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs. | The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability. | Posted | Mean | Standard Deviation | seconds | 3.5 weeks post-operatively |
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| Secondary | Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively | The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval. | The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability. | Posted | Mean | Standard Deviation | meters | 1 year post-operatively |
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| Secondary | Functional Performance Measure: Timed "Up & Go" Test [TUG] at 1 Year Post-operatively | The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance. | The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability. | Posted | Mean | Standard Deviation | seconds | 1 year post-operatively |
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| Secondary | Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively | The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs. | The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability. | Posted | Mean | Standard Deviation | seconds | 1 year post-operatively |
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Adverse event data were collected for a period of 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neuromuscular Electrical Stimulation (NMES) | Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy | 3 | 35 | 0 | 35 | ||
| EG001 | Standard Rehabilitation Protocol | Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery | 3 | 31 | 0 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-op complication | Surgical and medical procedures | Systematic Assessment |
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| DVT | Blood and lymphatic system disorders | Systematic Assessment |
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| Severe Sciatica | Nervous system disorders | Systematic Assessment |
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| Infection in the knee | Infections and infestations | Systematic Assessment |
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| C-Diff infection | Infections and infestations | Systematic Assessment |
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| TKA revision | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Stevens-Lapsley, PhD | University of Colorado Denver | 303-724-9170 | jennifer.stevens-lapsley@ucdenver.edu |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Male |
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