Chronic Kidney DiseaseNCT03160326
The QUALITY Vets Project: Muscle Quality and Kidney Disease
An observational study of Chronic Kidney Disease and Sarcopenia, run by Washington D.C. Veterans Affairs Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Chronic Kidney Disease, Sarcopenia
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
San Francisco VA Medical Center
San Francisco, California, 94121
Julie Doyle, 415-221-4810 ext. 2597, Julie.Doyle2@va.gov
Cynthia Delgado, MD
- Recruiting
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422
Brian M Hoover, MS, 202-745-8000 ext. 55826, Brian.Hoover@va.gov
Michael Harris-Love, DSc
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Disease, Sarcopenia
- Keywords
- chronic kidney disease, ultrasound, muscle loss
- Medical subject headings
- Renal Insufficiency, Chronic, Sarcopenia, Muscular Atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Quality
Muscle measurements at 6 sites using diagnostic ultrasound (grayscale levels, 0-255)
Measured: day 1
Lean Body Mass
Dual Energy X-ray Absorptiometry (DXA) scan (kg/m2)
Measured: day 1
Grip Strength
Measured using a dynamometer (kg)
Measured: day 1
Short Physical Performance Battery
Performance-based functional assessment battery; scores range from 0 (worst performance) to 12 (best performance)
Measured: day 1
Timed Up-and-Go
Performance-based fall risk assessment
Measured: day 1
Secondary outcomes (11)
Height
Participant height in meters
Measured: day 1
Weight
Participant weight in kilograms
Measured: day 1
Hip/waist circumference
Participant hip and waist circumference in centimeters
Measured: 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
Measured: day 1
Isometric peak knee extension force
Measured using a load cell
Measured: day 1
Activities-Specific Balance Confidence Scale
Mobility questionnaire
Measured: day 1
SF-36 - Physical Function Scale
General physical functioning questionnaire
Measured: day 1
Falls Efficacy Scale
Fall avoidance behavior questionnaire
Measured: day 1
Physical Activity Scale for the Elderly
Self-reported estimate physical activity
Measured: day 1
Sarcopenia-specific QoL scale (SarQoL)
Self-reported health-related quality of life
Measured: day 1
CES-D
Depression Scale
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study startSep 2016
- Primary completionOct 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Cynthia Delgado, MD, Principal investigator, San Francisco VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160326
- Sponsor's protocol ID
- AM-251-12-11-2015
- Status last verified
- Nov 2018
- First submitted
- 5 Oct 2016
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be shared between the two study sites: the Washington DC and San Francisco VA Medical Centers
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.
PubMed 34708217
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Quantitative Ultrasound Assessment of Lean and Intramuscular Adipose Tissue in Veterans With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03160326
- Acronym / sponsor ID
- AM-251-12-11-2015
- Conditions
- Chronic Kidney Disease, Sarcopenia
- Keywords
- chronic kidney disease, ultrasound, muscle loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Washington D.C. Veterans Affairs Medical CenterUS federal agency
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Study start
- Sep 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle Quality
Time frame: day 1
Muscle measurements at 6 sites using diagnostic ultrasound (grayscale levels, 0-255)
Lean Body Mass
Time frame: day 1
Dual Energy X-ray Absorptiometry (DXA) scan (kg/m2)
Grip Strength
Time frame: day 1
Measured using a dynamometer (kg)
Short Physical Performance Battery
Time frame: day 1
Performance-based functional assessment battery; scores range from 0 (worst performance) to 12 (best performance)
Timed Up-and-Go
Time frame: day 1
Performance-based fall risk assessment
11 secondary outcomes
Height
Time frame: day 1
Weight
Time frame: day 1
Hip/waist circumference
Time frame: day 1
Body composition
Time frame: day 1
Isometric peak knee extension force
Time frame: day 1
Activities-Specific Balance Confidence Scale
Time frame: day 1
SF-36 - Physical Function Scale
Time frame: day 1
Falls Efficacy Scale
Time frame: day 1
Physical Activity Scale for the Elderly
Time frame: day 1
Sarcopenia-specific QoL scale (SarQoL)
Time frame: day 1
CES-D
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Derived from this study: PubMed 34708217Gollie 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.
- Individual participant dataSharing planned: Yes. Data will be shared between the two study sites: the Washington DC and San Francisco VA Medical Centers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Delgado, MD principal investigator
San Francisco VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Sarcopenia, run by Washington D.C. Veterans Affairs Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Delgado, MD (415-221-4810 ext. 22592, Cynthia.Delgado@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Quality (time frame: day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03160326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.