Flywheel Exercise for CKD

Study Overview
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Brief Summary
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Among Veterans, the prevalence of chronic kidney disease (CKD) is reported to be as high as 47.3% and a third higher than the general population. Muscle wasting and dysfunction have been identified as primary consequences of CKD. Disease-induced reductions in lean tissue adversely affect muscle fatigability. Consequently, muscle fatigability may serve as a potential limiting factor that contributes to activity limitations. However, there is a lack of evidence informing our understanding of muscle fatigability in patients with CKD. Dialysis treatment is a major factor contributing to the high financial costs of CKD care. Thus, in addition to potential health and quality of life benefits, treatments capable of maintaining kidney function or delaying the onset of dialysis treatment would provide substantial socio-economic benefit. Both lean body mass and muscle fatigability may be improved through strength training. Eccentric-overload (i.e. muscle lengthening) progressive resistance exercise (PRE) has been shown to be safe and effective for a variety of chronic conditions. Eccentric PRE using portable flywheel technology may provide a clinically viable treatment option to combat muscle impairments in CKD given the cost effectiveness and minimal space requirements for this mode of exercise. The purpose of this study is to assess feasibility of the eccentric-overload PRE regimen for Veterans with CKD stage 3 & 4 predialysis using a prospective single-arm pre-test post-test intervention design. The primary aim of the project is to determine the effects of eccentric-overload PRE on muscle fatigability in Veterans with CKD Stages 3 & 4 predialysis. Feasibility of the regimen will be determined by the time needed to complete the 4-exercise regimen and the perceived exertion levels reported by the study participants.

Official Title
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Flywheel Resistance Exercise to Improve Skeletal Muscle in Veterans With Chronic Kidney Disease

Conditions
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Chronic Kidney Disease stage3, Chronic Kidney Disease stage4

Intervention / Treatment
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* Behavioral: Eccentric overload exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ambulatory patients (with or without a gait aid) CKD stage 3 or 4 patients receiving care at the DC VAMC Renal Service the ability to speak and read English orientation to person, place, and time Exclusion Criteria: unable to speak English acute renal failure pregnant unable to follow study instructions any uncontrolled cardiovascular or musculoskeletal problems that would make participation in this study unsafe

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eccentric overload exercise<br> | Behavioral: Eccentric overload exercise<br>* 12 weeks of 2x per week of the following eccentric exercises: squat, shoulder press, row, and bicep curl.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee extensor isokinetic muscle fatigability index at 12 weeks | Knee extensor muscle fatigability will be assessed using a protocol consisting of 30 repetitions or to failure, whichever comes first, at their maximum strength | Baseline, Week 12 | 
| Change in Muscle blood flow at 12 weeks | Blood flow will be assessed using Doppler ultrasound | Baseline, Week 12 | 
| Change in Isokinetic and isometric peak knee extension force at 12 weeks | Unilateral peak knee extension/flexion isokinetic force (at 180º/s and 60º/s) will be obtained across five continuous repetitions using a load cell | Baseline, Week 6, Week 12 | 
| Change in Short Physical Performance Battery at 12 weeks | This composite score is made up of measures of balance, gait speed (15 ft), and timed chair stands (x5). | Baseline, Week 12 | 
| Change in Timed Up-and-Go at 12 weeks | This test will begin the test with the subject fully sitting in a chair with arm rests, with the upright mobility portion of the test focused on an easily visible marked target 3 meters away from the chair | Baseline, Week 12 | 
| Change in Lean Body Mass, as estimated by diagnostic ultrasound at 12 weeks | Sonographic estimates of LBM (aggregate muscle thickness, cm) will serve as a proxy measure for muscle tissue composition in this study | Baseline, Week 6, Week 12 | 
| Change in myosteatosis, as estimated by diagnostic ultrasound at 12 weeks | Sonographic estimates of myosteatosis (grayscale, or GSL, values, 0-255) will serve as a proxy measure for muscle tissue composition in this study | Baseline, Week 6, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Grip strength at 12 weeks | This measure will be obtained with a hand grip dynamometer using the mean value of 3 trials under standardized conditions. | Baseline, Week 12 | 
| Change in Activities-Specific Balance Confidence (ABC) Scale at 12 weeks | mobility questionnaire; range 0-100, with higher values indicating higher confidence | Baseline, Week 12 | 
| Change in Short Form Health Survey (SF-36) Scale at 12 weeks | general physical functioning questionnaire; each of eight sections range 0-100 with higher values indicating less disability. The eight sections include vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. | Baseline, Week 12 | 
| Change in Falls Efficacy Scale (FES) at 12 weeks | fall avoidance behavior questionnaire; range 10-100, with lower values indicating greater efficacy | Baseline, Week 12 | 
| Change in weight at 12 weeks | Weight (in lbs) using bioelectric scale | Baseline, Week 6, Week 12 | 
| Change in height at 12 weeks | Height (in inches) using stadiometer | Baseline, Week 6, Week 12 | 
| Change in body water at 12 weeks | Body water (%) using bioelectric scale | Baseline, Week 6, Week 12 | 
| Change in Blood Pressure at 12 weeks | After sitting quietly for 5 minutes, resting blood pressure will be recorded in triplicate | Baseline, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resistance exercise, muscle fatigue, physical function