The QUALITY Vets Project: Muscle Quality and Kidney Disease

Study Overview
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Brief Summary
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Currently there is no standard way to detect age-related skeletal muscle loss in patients with chronic kidney disease. Investigators are working on finding rapid and inexpensive ways to measure muscle size and fat within the muscle.

Detailed Description
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The accelerated muscle wasting associated with chronic kidney disease (CKD) is a source of morbidity and an increased incidence of bone fracture secondary to falls. However, sarcopenia secondary to CKD is not routinely screened or assessed in this patient population. This protocol, Quantitative Ultrasound Assessment of Lean and Intramuscular Adipose Tissue in Veterans Project (i.e., QUALITY VETS) is a VA Center for Innovation (VACI) funded pilot study with the purpose of using a clinically viable sarcopenia screening approach for Veterans with CKD who are currently receiving care at the Renal Service. The investigative team will screen and assess diminished muscle mass, quality, and performance in Veterans with CKD (Stage 3 and 4), and also examine the relationship between the muscle characteristics and estimated fall risk within the sample. Key outcome measures will be obtained within the domains of muscle performance (peak grip strength), functional status (Short Physical Performance Battery), estimates of tissue/body composition (diagnostic ultrasound and DXA), and fall risk (Timed Up-and-Go test). Secondary measures will include questionnaires regarding of fall avoidance, physical activity, depression, and quality of life (QoL). The general analysis approach will be to characterize the proportion of participants with: sarcopenia based on the European Working Group on Sarcopenia in Older People (EWGSOP) algorithm, low muscle quality based on preliminary echogenicity cut off values and criterion strength values, and an elevated risk of falling based on the Timed Up-and-Go age-dependent cut off values. Investigators will determine the magnitude of association between the skeletal muscle outcomes and fall risk within the participant sample. Hazard ratios will be used to estimate the impact of the sarcopenia classification and echogenicity values on the positive classification of fall risk. The optimal treatment of Veterans with CKD who have an elevated risk of falls may be enhanced by the timely identification of accelerated muscle changes. The QUALITY-VETS Project will help to determine appropriate screening and assessment strategies that could be implemented in subsequent longitudinal studies involving exercise interventions and fall prevention training.

Official Title
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The Quantitative Ultrasound Assessment of Lean and Intramuscular Adipose Tissue in Veterans With Chronic Kidney Disease

Conditions
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Sarcopenia, Chronic Kidney Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory patients (with or without a gait aid) 18-84.9 years of age with CKD stage 3 or 4 Receiving care at the DC or SF VA Medical Center Renal Service Able to speak and read English Orientation to person, place, and time Exclusion Criteria: Acute renal failure Pregnancy Any uncontrolled cardiovascular or musculoskeletal disease that, in the opinion of the principal investigator, could make participation unsafe Body size exceeds the dimensional limits of the DXA scanner

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Quality | Muscle measurements at 6 sites using diagnostic ultrasound (grayscale levels, 0-255) | day 1 | 
| Lean Body Mass | Dual Energy X-ray Absorptiometry (DXA) scan (kg/m2) | day 1 | 
| Grip Strength | Measured using a dynamometer (kg) | day 1 | 
| Short Physical Performance Battery | Performance-based functional assessment battery; scores range from 0 (worst performance) to 12 (best performance) | day 1 | 
| Timed Up-and-Go | Performance-based fall risk assessment | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height | Participant height in meters | day 1 | 
| Weight | Participant weight in kilograms | day 1 | 
| Hip/waist circumference | Participant hip and waist circumference in centimeters | day 1 | 
| Body composition | Body composition data in presented in percentages of the body composed of water, bone, muscle, and fat using a bioelectric scale | day 1 | 
| Isometric peak knee extension force | Measured using a load cell | day 1 | 
| Activities-Specific Balance Confidence Scale | Mobility questionnaire | day 1 | 
| SF-36 - Physical Function Scale | General physical functioning questionnaire | day 1 | 
| Falls Efficacy Scale | Fall avoidance behavior questionnaire | day 1 | 
| Physical Activity Scale for the Elderly | Self-reported estimate physical activity | day 1 | 
| Sarcopenia-specific QoL scale (SarQoL) | Self-reported health-related quality of life | day 1 | 
| CES-D | Depression Scale | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, ultrasound, muscle loss