NCT04397159 · VA Office of Research and Development
Effects of Combination Exercise on Fatigability in Veterans With Chronic Kidney Disease
What this study is about
The VA health care system uses a health promotion-focused model which aims to provide longitudinal care through a patient-aligned care team for Veterans with chronic kidney disease.
View original scientific description
The VA health care system uses a health promotion-focused model which aims to provide longitudinal care through a patient-aligned care team for Veterans with chronic kidney disease. Since the largest subpopulation of Veterans with chronic kidney disease is comprised of those not requiring dialysis, neuromuscular screening assessments may provide valuable information regarding an individual overall health status and potential for future complications. Furthermore, identifying at risk individuals early in the disease process will allow for the prescription of timely interventions. Exercise strategies such as combination exercise, which uses flywheel resistance plus aerobic exercise, may provide a valuable treatment option for combating neuromuscular dysfunction and functional decline in patients with chronic kidney disease.
Interventions
BEHAVIORAL
Combination Exercise
Flywheel Resistance Plus Aerobic Exercise
Primary outcome measures
change in knee extensor fatigability
Time frame: week 6 and 12
Knee extensor fatigability will be assessed as changes in torque of the dominant leg during 30 contractions.
change in perceived fatigability
Time frame: week 6 and 12
Rating of perceived fatigability will be assessed using a 10-point scale with 0 indicating "not fatigued at all" and 10 indicating "absolutely exhausted". Low scores reflect lower perceived fatigability.
change in muscle blood flow
Time frame: week 6 and 12
Muscle blood flow of the vastus lateralis will be assessed using near-infrared spectroscopy and determined as the change in total hemoglobin during venous occlusion test.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Ambulatory (with or without a gait aid), 50 years of age or older diagnosed with chronic kidney disease (CKD) stages 3 \& 4 predialysis (as defined by eGFR 59-15 ml/min per 1.73m2)
- Control group will include ambulatory individuals without clinical evidence of kidney disease (defined by eGRF \>60 ml/min per 1.73m2) within the last 12-months
- All participants must be able to speak and read English, and demonstrate orientation to person, place, and time
Exclusion criteria
- adults diagnosed with acute renal failure/injury within the last 12-months
- non-ambulatory individuals
- adults who do not use the DC VAMC as their main site for renal care
- those who have any uncontrolled cardiovascular
- musculoskeletal disease
- or other conditions that, in the opinion of the principal investigator, could make participation in the study unsafe
- any orthopedic or joint pain which would prevent the participant from safely engaging in the study protocol
- additionally, individuals with plans to relocate from the DC metro area within one year will not be eligible for the intervention portion of the study
Where
- Washington D.C., District of Columbia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2026 · Source of record for eligibility and locations