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Effects of Combination Exercise on Fatigability in Veterans With Chronic 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: NCT04397159
Recruitment Status : Not yet recruiting
First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Predialysis Behavioral: Combination Exercise Phase 2

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, we 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Flywheel Resistance Plus Aerobic Exercise
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Objective and Subjective Measures of Fatigability in Veterans With Chronic Kidney Disease Before and After Flywheel Resistance Plus Aerobic Exercise
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combination Exercise
Flywheel resistance exercise plus aerobic exercise
Behavioral: Combination Exercise
Flywheel Resistance Plus Aerobic Exercise
Other Name: Flywheel Resistance Plus Aerobic Exercise

No Intervention: Standard-of-care
Participants will maintain standard-of-care and current activity levels during the course of the study.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. change in muscle oxygenation [ Time Frame: week 6 and 12 ]
    Muscle oxygenation of the vastus lateralis will be assessed using near-infrared spectroscopy and determined as the change in oxygenated hemo-myoglobin during repeated occlusion test.


Secondary Outcome Measures :
  1. change in muscle Quality [ Time Frame: week 12 ]
    Muscle quality of the vastus lateralis will be assessed using diagnostic ultrasound and determined using grayscale analysis.

  2. change in Sit-to-Stand [ Time Frame: week 12 ]
    Sit-to-stand test will be used to assess physical function and determined as the time taken to complete five sit-to-stand repetitions.

  3. change in rate of torque development [ Time Frame: week 12 ]
    Rate of torque development will be calculated as the change in torque over the change in time during isometric knee extensions.


Other Outcome Measures:
  1. change in muscle activation [ Time Frame: week 12 ]
    Muscle activation of the vastus lateralis will be determined using electromyography as the root mean square during isometric knee extensions.

  2. change in interleukin 6 (IL-6) and tumor necrosis factor alpha [ Time Frame: week 12 ]
    Interleukin 6 (IL-6) (pg/ml) and tumor necrosis factor alpha (pg/ml) will be assessed from blood samples.

  3. change in health-related quality of life [ Time Frame: week 12 ]
    Health-related quality of life will be assessed using the Short-form 36

  4. change in high density c-reactive protein [ Time Frame: week 12 ]
    Change in high density c-reactive protein (mg/L) will be assessed from blood samples.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT04397159


Contacts
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Contact: Jared M Gollie, PhD (202) 745-8000 Jared.Gollie@va.gov

Locations
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United States, District of Columbia
Washington DC VA Medical Center, Washington, DC
Washington, District of Columbia, United States, 20422
Contact: Jared M Gollie, PhD    202-745-8000    Jared.Gollie@va.gov   
Principal Investigator: Jared M. Gollie, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jared M. Gollie, PhD Washington DC VA Medical Center, Washington, DC
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04397159    
Other Study ID Numbers: F3423-W
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
fatigability
strength
rehabilitation
eccentric exercise
combination exercise
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency