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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease; Sarcopenia

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.

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • Recruiting
      • San Francisco VA Medical Center
      • Contact: Julie Doyle; Phone Number: 2597 415-221-4810; Email: Julie.Doyle2@va.gov
      • Principal Investigator: Cynthia Delgado, MD
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Recruiting
      • Washington DC VA Medical Center
      • Sub-Investigator: Haniel Hernandez, DPT
      • Sub-Investigator: Sholey Argani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participating Veterans in this study will undergo their standard examination by the DC or SF VA Medical Center Renal Service staff physicians and will be formally staged for CKD. Fifty adult patients with Stage 3 or 4 CKD (i.e., a definitive CKD diagnosis, but prior to the need for dialysis) will be enrolled following consent and then scheduled for the study assessments at their local study center.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington D.C. Veterans Affairs Medical Center
• Collaborators: San Francisco Veterans Affairs Medical Center
• Investigators: Principal Investigator: Cynthia Delgado, MD, San Francisco VA Medical Center

Publications and helpful links

General Publications

• Gollie JM, Harris-Love MO, Patel SS, Shara NM, Blackman MR. Rate of Force Development Is Related to Maximal Force and Sit-to-Stand Performance in Men With Stages 3b and 4 Chronic Kidney Disease. Front Rehabil Sci. 2021 Sep 28;2:734705. doi: 10.3389/fresc.2021.734705.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: ultrasound; chronic kidney disease; muscle loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Neurologic Manifestations; Renal Insufficiency; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Kidney Diseases; Renal Insufficiency, Chronic; Sarcopenia
• Other Study ID Numbers: AM-251-12-11-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be shared between the two study sites: the Washington DC and San Francisco VA Medical Centers