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Flywheel Exercise for CKD

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03582982
Enrollment
20
Registered
2018-07-11
Start date
2018-05-16
Completion date
2020-02-01
Last updated
2018-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease stage3, Chronic Kidney Disease stage4

Keywords

resistance exercise, muscle fatigue, physical function

Brief summary

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.

Interventions

BEHAVIORALEccentric overload exercise

12 weeks of 2x per week of the following eccentric exercises: squat, shoulder press, row, and bicep curl.

Sponsors

Washington D.C. Veterans Affairs Medical Center
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Muscle blood flow at 12 weeksBaseline, Week 12Blood flow will be assessed using Doppler ultrasound
Change in Knee extensor isokinetic muscle fatigability index at 12 weeksBaseline, Week 12Knee extensor muscle fatigability will be assessed using a protocol consisting of 30 repetitions or to failure, whichever comes first, at their maximum strength
Change in Isokinetic and isometric peak knee extension force at 12 weeksBaseline, Week 6, Week 12Unilateral peak knee extension/flexion isokinetic force (at 180º/s and 60º/s) will be obtained across five continuous repetitions using a load cell
Change in Short Physical Performance Battery at 12 weeksBaseline, Week 12This composite score is made up of measures of balance, gait speed (15 ft), and timed chair stands (x5).
Change in Timed Up-and-Go at 12 weeksBaseline, Week 12This 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
Change in Lean Body Mass, as estimated by diagnostic ultrasound at 12 weeksBaseline, Week 6, Week 12Sonographic estimates of LBM (aggregate muscle thickness, cm) will serve as a proxy measure for muscle tissue composition in this study
Change in myosteatosis, as estimated by diagnostic ultrasound at 12 weeksBaseline, Week 6, Week 12Sonographic estimates of myosteatosis (grayscale, or GSL, values, 0-255) will serve as a proxy measure for muscle tissue composition in this study

Secondary

MeasureTime frameDescription
Change in Grip strength at 12 weeksBaseline, Week 12This measure will be obtained with a hand grip dynamometer using the mean value of 3 trials under standardized conditions.
Change in Blood Pressure at 12 weeksBaseline, Week 12After sitting quietly for 5 minutes, resting blood pressure will be recorded in triplicate
Change in Activities-Specific Balance Confidence (ABC) Scale at 12 weeksBaseline, Week 12mobility questionnaire; range 0-100, with higher values indicating higher confidence
Change in Short Form Health Survey (SF-36) Scale at 12 weeksBaseline, Week 12general 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.
Change in Falls Efficacy Scale (FES) at 12 weeksBaseline, Week 12fall avoidance behavior questionnaire; range 10-100, with lower values indicating greater efficacy
Change in weight at 12 weeksBaseline, Week 6, Week 12Weight (in lbs) using bioelectric scale
Change in height at 12 weeksBaseline, Week 6, Week 12Height (in inches) using stadiometer
Change in body water at 12 weeksBaseline, Week 6, Week 12Body water (%) using bioelectric scale

Countries

United States

Contacts

Primary ContactJared M Gollie, PhD
Jared.Gollie@va.gov202-745-8000
Backup ContactBrian M Hoover, MS
Brian.Hoover@va.gov202-745-8000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026