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Flywheel Exercise for CKD

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ClinicalTrials.gov Identifier: NCT03582982
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Washington D.C. Veterans Affairs Medical Center

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease stage3 Chronic Kidney Disease stage4 Behavioral: Eccentric overload exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Flywheel Resistance Exercise to Improve Skeletal Muscle in Veterans With Chronic Kidney Disease
Actual Study Start Date : May 16, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Knee extensor isokinetic muscle fatigability index at 12 weeks [ Time Frame: Baseline, Week 12 ]
    Knee extensor muscle fatigability will be assessed using a protocol consisting of 30 repetitions or to failure, whichever comes first, at their maximum strength

  2. Change in Muscle blood flow at 12 weeks [ Time Frame: Baseline, Week 12 ]
    Blood flow will be assessed using Doppler ultrasound

  3. Change in Isokinetic and isometric peak knee extension force at 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
    Unilateral peak knee extension/flexion isokinetic force (at 180º/s and 60º/s) will be obtained across five continuous repetitions using a load cell

  4. Change in Short Physical Performance Battery at 12 weeks [ Time Frame: Baseline, Week 12 ]
    This composite score is made up of measures of balance, gait speed (15 ft), and timed chair stands (x5).

  5. Change in Timed Up-and-Go at 12 weeks [ Time Frame: Baseline, Week 12 ]
    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

  6. Change in Lean Body Mass, as estimated by diagnostic ultrasound at 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
    Sonographic estimates of LBM (aggregate muscle thickness, cm) will serve as a proxy measure for muscle tissue composition in this study

  7. Change in myosteatosis, as estimated by diagnostic ultrasound at 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
    Sonographic estimates of myosteatosis (grayscale, or GSL, values, 0-255) will serve as a proxy measure for muscle tissue composition in this study


Secondary Outcome Measures :
  1. Change in Grip strength at 12 weeks [ Time Frame: Baseline, Week 12 ]
    This measure will be obtained with a hand grip dynamometer using the mean value of 3 trials under standardized conditions.

  2. Change in Activities-Specific Balance Confidence (ABC) Scale at 12 weeks [ Time Frame: Baseline, Week 12 ]
    mobility questionnaire; range 0-100, with higher values indicating higher confidence

  3. Change in Short Form Health Survey (SF-36) Scale at 12 weeks [ Time Frame: Baseline, Week 12 ]
    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.

  4. Change in Falls Efficacy Scale (FES) at 12 weeks [ Time Frame: Baseline, Week 12 ]
    fall avoidance behavior questionnaire; range 10-100, with lower values indicating greater efficacy

  5. Change in weight at 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
    Weight (in lbs) using bioelectric scale

  6. Change in height at 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
    Height (in inches) using stadiometer

  7. Change in body water at 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
    Body water (%) using bioelectric scale

  8. Change in Blood Pressure at 12 weeks [ Time Frame: Baseline, Week 12 ]
    After sitting quietly for 5 minutes, resting blood pressure will be recorded in triplicate



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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582982


Contacts
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Contact: Jared M Gollie, PhD 202-745-8000 ext 55851 Jared.Gollie@va.gov
Contact: Brian M Hoover, MS 202-745-8000 ext 55826 Brian.Hoover@va.gov

Locations
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United States, District of Columbia
Washington DC VA Medical Center Recruiting
Washington, District of Columbia, United States, 20422
Contact: Jared M Gollie, PhD    202-745-8000 ext 55851    Jared.Gollie@va.gov   
Contact: Brian M Hoover, MS    202-745-8000 ext 55826    Brian.Hoover@va.gov   
Principal Investigator: Michael O Harris-Love, DSc         
Sponsors and Collaborators
Washington D.C. Veterans Affairs Medical Center
Investigators
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Principal Investigator: Michael O Harris-Love, DSc Washington DC VA Medical Center

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Responsible Party: Washington D.C. Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03582982     History of Changes
Other Study ID Numbers: 01903
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington D.C. Veterans Affairs Medical Center:
resistance exercise
muscle fatigue
physical function
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency