The QUALITY Vets Project: Muscle Quality and Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03160326
• Other study ID #: AM-251-12-11-2015
• Status: Recruiting
• Start date: September 2016
• Est. completion date: March 2020

Study information

• Verified date: November 2018
• Source: Washington D.C. Veterans Affairs Medical Center
• Contact: Cynthia Delgado, MD
• Phone: 415-221-4810
• Email: Cynthia.Delgado[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: March 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Sarcopenia

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California
United States	Washington DC VA Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Washington D.C. Veterans Affairs Medical Center	San Francisco Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Quality	Muscle measurements at 6 sites using diagnostic ultrasound (grayscale levels, 0-255)	day 1
Primary	Lean Body Mass	Dual Energy X-ray Absorptiometry (DXA) scan (kg/m2)	day 1
Primary	Grip Strength	Measured using a dynamometer (kg)	day 1
Primary	Short Physical Performance Battery	Performance-based functional assessment battery; scores range from 0 (worst performance) to 12 (best performance)	day 1
Primary	Timed Up-and-Go	Performance-based fall risk assessment	day 1
Secondary	Height	Participant height in meters	day 1
Secondary	Weight	Participant weight in kilograms	day 1
Secondary	Hip/waist circumference	Participant hip and waist circumference in centimeters	day 1
Secondary	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
Secondary	Isometric peak knee extension force	Measured using a load cell	day 1
Secondary	Activities-Specific Balance Confidence Scale	Mobility questionnaire	day 1
Secondary	SF-36 - Physical Function Scale	General physical functioning questionnaire	day 1
Secondary	Falls Efficacy Scale	Fall avoidance behavior questionnaire	day 1
Secondary	Physical Activity Scale for the Elderly	Self-reported estimate physical activity	day 1
Secondary	Sarcopenia-specific QoL scale (SarQoL)	Self-reported health-related quality of life	day 1
Secondary	CES-D	Depression Scale	day 1