The QUALITY Vets Project: Muscle Quality and Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Roles of Uremic Toxins in Uremic Sacropenia

NCT03060590

Sarcopenia

COMPLETED

The Relationship Between Sarcopenia and Cardiovascular Disease in Chronic Kidney Disease and the Risk Involved.

NCT05479331

Sarcopenia CKD Cardiovascular Diseases

COMPLETED

Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease

NCT04330807

Chronic Kidney Disease Stage 3B Chronic Kidney Disease stage4 Chronic Kidney Disease Stage 5 +1 more

UNKNOWN NA

Critical Illness Myopathy and Trajectory of Recovery in AKI Requiring CRRT

NCT05287204

Acute Kidney Injury Critical Illness Myopathy Dialysis; Complications

ACTIVE_NOT_RECRUITING

Chronic Kidney Disease-related Sarcopenia With Poor Prognosis

NCT05353660

Chronic Kidney Diseases Sarcopenia

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease Sarcopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No