Flywheel Exercise for CKD

NCT03582982 | Unknown

• 1 other identifier: 01903
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease stage3; Chronic Kidney Disease stage4

Keywords

resistance exercise; muscle fatigue; physical function

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (8)

• Change in Grip strength at 12 weeks

  Baseline, Week 12

• Change in Activities-Specific Balance Confidence (ABC) Scale at 12 weeks

  Baseline, Week 12

• Change in Short Form Health Survey (SF-36) Scale at 12 weeks

  Baseline, Week 12

• Change in Falls Efficacy Scale (FES) at 12 weeks

  Baseline, Week 12

• Change in weight at 12 weeks

  Baseline, Week 6, Week 12

Study Arms (1)

Eccentric overload exercise

EXPERIMENTAL

Behavioral: Eccentric overload exercise

Interventions

Eccentric overload exercise BEHAVIORAL

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

Eccentric overload exercise

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington D.C. Veterans Affairs Medical Center: lead

Study Sites (1)

Washington DC VA Medical Center

Washington D.C., District of Columbia, 20422, United States

RECRUITING

Study Officials

• Michael O Harris-Love, DSc

  Washington DC VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jared M Gollie, PhD

CONTACT

202-745-8000; Jared.Gollie@va.gov

Brian M Hoover, MS

CONTACT

202-745-8000; Brian.Hoover@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 11, 2018
• Study Start: May 16, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2020
• Last Updated: November 9, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)