Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The QUALITY Vets Project: Muscle Quality and Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03160326
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
San Francisco Veterans Affairs Medical Center
Information provided by (Responsible Party):
Washington D.C. Veterans Affairs Medical Center

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.

Condition or disease
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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Quantitative Ultrasound Assessment of Lean and Intramuscular Adipose Tissue in Veterans With Chronic Kidney Disease
Study Start Date : September 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases




Primary Outcome Measures :
  1. Muscle Quality [ Time Frame: day 1 ]
    Muscle measurements at 6 sites using diagnostic ultrasound (grayscale levels, 0-255)

  2. Lean Body Mass [ Time Frame: day 1 ]
    Dual Energy X-ray Absorptiometry (DXA) scan (kg/m2)

  3. Grip Strength [ Time Frame: day 1 ]
    Measured using a dynamometer (kg)

  4. Short Physical Performance Battery [ Time Frame: day 1 ]
    Performance-based functional assessment battery; scores range from 0 (worst performance) to 12 (best performance)

  5. Timed Up-and-Go [ Time Frame: day 1 ]
    Performance-based fall risk assessment


Secondary Outcome Measures :
  1. Height [ Time Frame: day 1 ]
    Participant height in meters

  2. Weight [ Time Frame: day 1 ]
    Participant weight in kilograms

  3. Hip/waist circumference [ Time Frame: day 1 ]
    Participant hip and waist circumference in centimeters

  4. Body composition [ Time Frame: day 1 ]
    Body composition data in presented in percentages of the body composed of water, bone, muscle, and fat using a bioelectric scale

  5. Isometric peak knee extension force [ Time Frame: day 1 ]
    Measured using a load cell

  6. Activities-Specific Balance Confidence Scale [ Time Frame: day 1 ]
    Mobility questionnaire

  7. SF-36 - Physical Function Scale [ Time Frame: day 1 ]
    General physical functioning questionnaire

  8. Falls Efficacy Scale [ Time Frame: day 1 ]
    Fall avoidance behavior questionnaire

  9. Physical Activity Scale for the Elderly [ Time Frame: day 1 ]
    Self-reported estimate physical activity

  10. Sarcopenia-specific QoL scale (SarQoL) [ Time Frame: day 1 ]
    Self-reported health-related quality of life

  11. CES-D [ Time Frame: day 1 ]
    Depression Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160326


Contacts
Layout table for location contacts
Contact: Cynthia Delgado, MD 415-221-4810 ext 22592 Cynthia.Delgado@ucsf.edu
Contact: Michael Harris-Love, DSc 202-745-8000 ext 57640 Michael.Harris-Love@va.gov

Locations
Layout table for location information
United States, California
San Francisco VA Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Julie Doyle    415-221-4810 ext 2597    Julie.Doyle2@va.gov   
Principal Investigator: Cynthia Delgado, MD         
United States, District of Columbia
Washington DC VA Medical Center Recruiting
Washington, District of Columbia, United States, 20422
Contact: Brian M Hoover, MS    202-745-8000 ext 55826    Brian.Hoover@va.gov   
Principal Investigator: Michael Harris-Love, DSc         
Sub-Investigator: Haniel Hernandez, DPT         
Sub-Investigator: Sholey Argani, MD         
Sub-Investigator: Marc Blackman, MD         
Sponsors and Collaborators
Washington D.C. Veterans Affairs Medical Center
San Francisco Veterans Affairs Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Cynthia Delgado, MD San Francisco VA Medical Center

Layout table for additonal information
Responsible Party: Washington D.C. Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03160326     History of Changes
Other Study ID Numbers: AM-251-12-11-2015
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared between the two study sites: the Washington DC and San Francisco VA Medical Centers

Keywords provided by Washington D.C. Veterans Affairs Medical Center:
chronic kidney disease
ultrasound
muscle loss

Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Sarcopenia
Urologic Diseases
Renal Insufficiency
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms