Clinical trial NCT04397159: Effects of Combination Exercise on Fatigability in Veterans With Chronic Kidney Disease
Official title: Objective and Subjective Measures of Fatigability in Veterans With Chronic Kidney Disease Before and After Flywheel Resistance Plus Aerobic Exercise
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease Predialysis
Keywords: fatigability
strength
rehabilitation
eccentric exercise
combination exercise
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-05-21
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Flywheel Resistance Plus Aerobic Exercise
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in knee extensor fatigability
timeFrame: week 6 and 12
measure: change in perceived fatigability
timeFrame: week 6 and 12
measure: change in muscle blood flow
timeFrame: week 6 and 12
Secondary outcomes:
measure: change in muscle Quality
timeFrame: week 12
measure: change in Sit-to-Stand
timeFrame: week 12
measure: change in rate of torque development
timeFrame: week 12
Other outcomes:
measure: change in muscle activation
timeFrame: week 12
measure: change in interleukin 6 (IL-6) and tumor necrosis factor alpha
timeFrame: week 12
measure: change in health-related quality of life
timeFrame: week 12
measure: change in high density c-reactive protein
timeFrame: week 12
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center, Washington, DC
state: District of Columbia
Study officials:
affiliation: Washington DC VA Medical Center, Washington, DC
name: Jared M. Gollie, PhD
role: PRINCIPAL_INVESTIGATOR
References: