Flywheel Exercise for CKD

Chronic Kidney Disease stage4 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03582982
• Other study ID #: 01903
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: November 2018
• Source: Washington D.C. Veterans Affairs Medical Center
• Contact: Jared M Gollie, PhD
• Phone: 202-745-8000
• Email: Jared.Gollie[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease stage3
• Chronic Kidney Disease stage4
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Washington DC VA Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Washington D.C. Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Muscle blood flow at 12 weeks	Blood flow will be assessed using Doppler ultrasound	Baseline, Week 12
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in weight at 12 weeks	Weight (in lbs) using bioelectric scale	Baseline, Week 6, Week 12
Secondary	Change in height at 12 weeks	Height (in inches) using stadiometer	Baseline, Week 6, Week 12
Secondary	Change in body water at 12 weeks	Body water (%) using bioelectric scale	Baseline, Week 6, Week 12
Secondary	Change in Blood Pressure at 12 weeks	After sitting quietly for 5 minutes, resting blood pressure will be recorded in triplicate	Baseline, Week 12