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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

Tracking Information
First Submitted Date  ICMJE June 15, 2018
First Posted Date  ICMJE July 11, 2018
Last Update Posted Date November 9, 2018
Actual Study Start Date  ICMJE May 16, 2018
Estimated Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
  • 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
  • Change in Muscle blood flow at 12 weeks [ Time Frame: Baseline, Week 12 ]
    Blood flow will be assessed using Doppler ultrasound
  • 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
  • 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).
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03582982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • 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.
  • 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
  • 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.
  • 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
  • Change in weight at 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
    Weight (in lbs) using bioelectric scale
  • Change in height at 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
    Height (in inches) using stadiometer
  • Change in body water at 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
    Body water (%) using bioelectric scale
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
  • 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.
  • 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
  • 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.
  • 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
  • Change in Anthropometrics at 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
    Weight/height/body water using bioelectric scale and stadiometer
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Flywheel Exercise for CKD
Official Title  ICMJE Flywheel Resistance Exercise to Improve Skeletal Muscle in Veterans With Chronic Kidney Disease
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Chronic Kidney Disease stage3
  • Chronic Kidney Disease stage4
Intervention  ICMJE Behavioral: Eccentric overload exercise
12 weeks of 2x per week of the following eccentric exercises: squat, shoulder press, row, and bicep curl.
Study Arms  ICMJE Experimental: Eccentric overload exercise
Intervention: Behavioral: Eccentric overload exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2020
Estimated Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03582982
Other Study ID Numbers  ICMJE 01903
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington D.C. Veterans Affairs Medical Center
Study Sponsor  ICMJE Washington D.C. Veterans Affairs Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael O Harris-Love, DSc Washington DC VA Medical Center
PRS Account Washington D.C. Veterans Affairs Medical Center
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP