Chronic Kidney Disease PredialysisNCT04397159
Effects of Combination Exercise on Fatigability in Veterans With Chronic Kidney Disease
A study testing Combination Exercise in people with Chronic Kidney Disease Predialysis, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease Predialysis
- What is being tested?
- Combination Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422-0001
Jared M Gollie, PhD, 202-745-8000, Jared.Gollie@va.gov
Jared M. Gollie, PhD
About this study
Official title: Objective and Subjective Measures of Fatigability in Veterans With Chronic Kidney Disease Before and After Flywheel Resistance Plus Aerobic Exercise
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.
Read the detailed description
Chronic kidney disease (CKD) is a complex medical condition affecting as much as 36% of the Veteran population. Both empirical and anecdotal evidence identify elevations in fatigability as a major health concern in Veterans with CKD predialysis. Neuromuscular deteriorations resulting from CKD are likely to contribute to excessive fatigability, impacting an individual's functional status. Flywheel resistance exercise (FRE) uses inertial resistance to allow for optimal muscle loading through the entire concentric muscle action and promotes greater eccentric force generation compared to traditional resistance exercise. FRE has been shown to be superior to traditional resistance exercise for improving muscle strength, power, and physical function in healthy populations suggesting it may be a useful treatment for addressing neuromuscular impairments and functional decline. However, it is unclear if the addition of aerobic exercise to FRE would provide additive improvements in fatigue resistance in patients with CKD, without compromising neuromuscular and functional benefits. The purpose of this project is to (1) advance the understanding of performance fatigability and perceived fatigability, and the association with neuromuscular capacity in Veterans with CKD stage 3 \& 4 predialysis and (2) determine the extent to which combination FRE plus aerobic exercise training can improve fatigability status, neuromuscular capacity, and physical function in Veterans with CKD stage 3 \& 4 predialysis. The central hypothesis is that reductions in neuromuscular capacity are associated with increases in fatigability severity, and that FRE plus aerobic exercise training will reduce fatigability severity while enhancing neuromuscular and functional capabilities in Veterans with CKD stage 3 \& 4 predialysis. To address this hypothesis, researchers will characterize performance fatigability and perceived fatigability, and assess the associations between fatigability outcomes and neuromuscular capacity in Veterans with CKD stage 3 \& 4 predialysis and examine the effects of 12-weeks of FRE plus aerobic exercise training on changes in performance and perceived fatigability, neuromuscular capacity, and physical function in Veterans with CKD stage 3 \& 4 predialysis. Findings from this project will provide valuable information for advancing the understanding of performance fatigability and perceived fatigability, and their inter-relationship, in Veterans with CKD stages 3 and 4. Additionally, novel evidence on the responsiveness of performance and perceived fatigability, neuromuscular capacity, and quality of life to FRE plus aerobic exercise training will be gained.
- Conditions
- Chronic Kidney Disease Predialysis
- Being tested
- Combination Exercise
- Keywords
- fatigability, strength, rehabilitation, eccentric exercise, combination exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination ExerciseBehavioural
Also called Flywheel Resistance Plus Aerobic Exercise
Flywheel Resistance Plus Aerobic Exercise
| Study group | Role | What they receive |
|---|---|---|
| Combination Exercise | Experimental | Flywheel resistance exercise plus aerobic exercise Receives: Behavioral: Combination Exercise |
| Standard-of-care | No intervention | Participants will maintain standard-of-care and current activity levels during the course of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in knee extensor fatigability
Knee extensor fatigability will be assessed as changes in torque of the dominant leg during 30 contractions.
Measured: week 6 and 12
change in perceived fatigability
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.
Measured: week 6 and 12
change in muscle blood flow
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.
Measured: week 6 and 12
Secondary outcomes (3)
change in muscle Quality
Muscle quality of the vastus lateralis will be assessed using diagnostic ultrasound and determined using grayscale analysis.
Measured: week 12
change in Sit-to-Stand
Sit-to-stand test will be used to assess physical function and determined as the time taken to complete five sit-to-stand repetitions.
Measured: week 12
change in rate of torque development
Rate of torque development will be calculated as the change in torque over the change in time during isometric knee extensions.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Jun 2022
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease PredialysisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Flywheel Resistance Plus Aerobic Exercise
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jared M. Gollie, PhD, Principal investigator, Washington DC VA Medical Center, Washington, DC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397159
- Sponsor's protocol ID
- F3423-W
- Status last verified
- Mar 2026
- First submitted
- 13 May 2020
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective and Subjective Measures of Fatigability in Veterans With Chronic Kidney Disease Before and After Flywheel Resistance Plus Aerobic Exercise
- ClinicalTrials.gov ID
- NCT04397159
- Acronym / sponsor ID
- F3423-W
- Conditions
- Chronic Kidney Disease Predialysis
- Keywords
- fatigability, strength, rehabilitation, eccentric exercise, combination exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 21 May 2020 (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.
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.
Detailed description
Chronic kidney disease (CKD) is a complex medical condition affecting as much as 36% of the Veteran population. Both empirical and anecdotal evidence identify elevations in fatigability as a major health concern in Veterans with CKD predialysis. Neuromuscular deteriorations resulting from CKD are likely to contribute to excessive fatigability, impacting an individual's functional status. Flywheel resistance exercise (FRE) uses inertial resistance to allow for optimal muscle loading through the entire concentric muscle action and promotes greater eccentric force generation compared to traditional resistance exercise. FRE has been shown to be superior to traditional resistance exercise for improving muscle strength, power, and physical function in healthy populations suggesting it may be a useful treatment for addressing neuromuscular impairments and functional decline. However, it is unclear if the addition of aerobic exercise to FRE would provide additive improvements in fatigue resistance in patients with CKD, without compromising neuromuscular and functional benefits. The purpose of this project is to (1) advance the understanding of performance fatigability and perceived fatigability, and the association with neuromuscular capacity in Veterans with CKD stage 3 \& 4 predialysis and (2) determine the extent to which combination FRE plus aerobic exercise training can improve fatigability status, neuromuscular capacity, and physical function in Veterans with CKD stage 3 \& 4 predialysis. The central hypothesis is that reductions in neuromuscular capacity are associated with increases in fatigability severity, and that FRE plus aerobic exercise training will reduce fatigability severity while enhancing neuromuscular and functional capabilities in Veterans with CKD stage 3 \& 4 predialysis. To address this hypothesis, researchers will characterize performance fatigability and perceived fatigability, and assess the associations between fatigability outcomes and neuromuscular capacity in Veterans with CKD stage 3 \& 4 predialysis and examine the effects of 12-weeks of FRE plus aerobic exercise training on changes in performance and perceived fatigability, neuromuscular capacity, and physical function in Veterans with CKD stage 3 \& 4 predialysis. Findings from this project will provide valuable information for advancing the understanding of performance fatigability and perceived fatigability, and their inter-relationship, in Veterans with CKD stages 3 and 4. Additionally, novel evidence on the responsiveness of performance and perceived fatigability, neuromuscular capacity, and quality of life to FRE plus aerobic exercise training will be gained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Flywheel Resistance Plus Aerobic Exercise
| Arm | Type | Receives |
|---|---|---|
| Combination Exercise | Experimental | Behavioral: Combination ExerciseFlywheel resistance exercise plus aerobic exercise |
| Standard-of-care | No intervention | –Participants will maintain standard-of-care and current activity levels during the course of the study. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination ExerciseAlso: Flywheel Resistance Plus Aerobic ExerciseFlywheel Resistance Plus Aerobic Exercise | Behavioural | Combination Exercise |
Primary outcome
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.
3 secondary outcomes
change in muscle Quality
Time frame: week 12
change in Sit-to-Stand
Time frame: week 12
change in rate of torque development
Time frame: week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease Predialysis
Not yet recruitingObservational study
Predictors of Rapid CKD Progression
Chronic Kidney Diseases, Kidney Failure
Active, not recruiting
EFFECTS OF TELENURSING IN PREDIALYSIS PATIENTS
Telenurse, CKD Stage 3/4
Not yet recruiting
Synbiotic Supplementation and Inflammation in Predialysis Chronic Kidney Disease
Chronic Kidney Disease, Inflammation
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.
Jared M. Gollie, PhD principal investigator
Washington DC VA Medical Center, Washington, DC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination Exercise in people with Chronic Kidney Disease Predialysis, run by VA Office of Research and Development at 1 site 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jared M Gollie, PhD ((202) 745-8000, Jared.Gollie@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in knee extensor fatigability (time frame: week 6 and 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.