Flywheel Exercise for CKD

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease stage4; Chronic Kidney Disease stage3
• Intervention / Treatment: Behavioral: Eccentric overload exercise

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Recruiting
      • Washington DC VA Medical Center
      • Contact: Jared M Gollie, PhD; Phone Number: 55851 202-745-8000; Email: Jared.Gollie@va.gov
      • Principal Investigator: Michael O Harris-Love, DSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington D.C. Veterans Affairs Medical Center
• Investigators: Principal Investigator: Michael O Harris-Love, DSc, Washington DC VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 11, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: resistance exercise; physical function; muscle fatigue
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 01903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No