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The QUALITY Vets Project: Muscle Quality and Kidney Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03160326
Enrollment
75
Registered
2017-05-19
Start date
2016-09-30
Completion date
2020-03-31
Last updated
2018-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Sarcopenia

Keywords

chronic kidney disease, ultrasound, muscle loss

Brief summary

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

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.

Interventions

None listed

Sponsors

San Francisco Veterans Affairs Medical Center
CollaboratorFED
Washington D.C. Veterans Affairs Medical Center
Lead SponsorFED

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lean Body Massday 1Dual Energy X-ray Absorptiometry (DXA) scan (kg/m2)
Short Physical Performance Batteryday 1Performance-based functional assessment battery; scores range from 0 (worst performance) to 12 (best performance)
Timed Up-and-Goday 1Performance-based fall risk assessment
Muscle Qualityday 1Muscle measurements at 6 sites using diagnostic ultrasound (grayscale levels, 0-255)
Grip Strengthday 1Measured using a dynamometer (kg)

Secondary

MeasureTime frameDescription
Isometric peak knee extension forceday 1Measured using a load cell
Activities-Specific Balance Confidence Scaleday 1Mobility questionnaire
SF-36 - Physical Function Scaleday 1General physical functioning questionnaire
Falls Efficacy Scaleday 1Fall avoidance behavior questionnaire
Physical Activity Scale for the Elderlyday 1Self-reported estimate physical activity
Sarcopenia-specific QoL scale (SarQoL)day 1Self-reported health-related quality of life
CES-Dday 1Depression Scale
Heightday 1Participant height in meters
Weightday 1Participant weight in kilograms
Hip/waist circumferenceday 1Participant hip and waist circumference in centimeters
Body compositionday 1Body composition data in presented in percentages of the body composed of water, bone, muscle, and fat using a bioelectric scale

Countries

United States

Contacts

Primary ContactCynthia Delgado, MD
Cynthia.Delgado@ucsf.edu415-221-4810
Backup ContactMichael Harris-Love, DSc
Michael.Harris-Love@va.gov202-745-8000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026