Skeletal Muscle Atrophy and Dysfunction Following Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03051984|
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Device: Neuromuscular electrical stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Skeletal Muscle Atrophy and Dysfunction Following Total Knee Arthroplasty|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Neuromuscular electrical stimulation (NMES) will be administered for 5 weeks post-TKA in the quadriceps of the surgical leg. Treatment will occur 5 days per week, twice daily for 45 minutes on each occasion.
Device: Neuromuscular electrical stimulation
NMES will be conducted on the quadriceps of the operative leg using a portable stimulation device, starting within 48-72 hrs of surgery. The operative leg will be immobilized at a neutral angle (~30º), with electrodes affixed to the anterior surface of the thigh. Symmetrical, biphasic pulses (400 µs duration at 50 Hz) will be used, with a duty cycle of 25% (10 s on, 30 s off), with patient-selected stimulation intensity to cause visible contractions below pain threshold. NMES sessions will occur 5 d/week, twice daily for 45 min (5 min warm-up) for 5 wks.
Other Name: NMES
No Intervention: Control
No intervention will be administered during the 5 weeks post-TKA in the surgical leg.
- Cross-sectional area of muscle fibers [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
- Intermyofibrillar mitochondrial content [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy
- Maximal calcium-activated tension single muscle fiber tension and shortening velocity [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition and shortening velocity will be evaluated from isotonic load clamps, with muscle fiber type determined post-measurement by gel electrophoresis
- Mitochondrial function [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Oxygen consumption rate of isolated muscle mitochondria under adenosine diphosphate stimulation and hydrogen peroxide production
- Physical activity level [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Physical activity will be assessed by accelerometry.
- Quadriceps muscle cross-sectional area [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Quadriceps muscle cross-sectional area will be assessed by computed tomography at the mid-thigh.
- Physical functional measures [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Whole body physical function will be assessed.
- Whole muscle strength [ Time Frame: Change from baseline cross-sectional area at 5 weeks ]Knee extensor isometric and isokinetic strength will be assessed by dynamometry.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051984
|Contact: Michael J Toth, PhDfirstname.lastname@example.org|
|Contact: Patrick Savageemail@example.com|
|United States, Vermont|
|University of Vermont College of Medicine||Recruiting|
|Burlington, Vermont, United States, 05405|
|Contact: Patrick Savage 802-847-4545 firstname.lastname@example.org|