Flywheel Exercise for CKD
Primary Purpose
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eccentric overload exercise
Sponsored by
About this trial
This is an interventional other trial for Chronic Kidney Disease stage3 focused on measuring resistance exercise, muscle fatigue, physical function
Eligibility 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
Sites / Locations
- Washington DC VA Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eccentric overload exercise
Arm Description
Outcomes
Primary Outcome Measures
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
Change in Muscle blood flow at 12 weeks
Blood flow will be assessed using Doppler ultrasound
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
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).
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
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
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
Secondary Outcome Measures
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.
Change in Activities-Specific Balance Confidence (ABC) Scale at 12 weeks
mobility questionnaire; range 0-100, with higher values indicating higher confidence
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.
Change in Falls Efficacy Scale (FES) at 12 weeks
fall avoidance behavior questionnaire; range 10-100, with lower values indicating greater efficacy
Change in weight at 12 weeks
Weight (in lbs) using bioelectric scale
Change in height at 12 weeks
Height (in inches) using stadiometer
Change in body water at 12 weeks
Body water (%) using bioelectric scale
Change in Blood Pressure at 12 weeks
After sitting quietly for 5 minutes, resting blood pressure will be recorded in triplicate
Full Information
NCT ID
NCT03582982
First Posted
June 15, 2018
Last Updated
November 8, 2018
Sponsor
Washington D.C. Veterans Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03582982
Brief Title
Flywheel Exercise for CKD
Official Title
Flywheel Resistance Exercise to Improve Skeletal Muscle in Veterans With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 16, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington D.C. Veterans Affairs Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
Keywords
resistance exercise, muscle fatigue, physical function
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eccentric overload exercise
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Eccentric overload exercise
Intervention Description
12 weeks of 2x per week of the following eccentric exercises: squat, shoulder press, row, and bicep curl.
Primary Outcome Measure Information:
Title
Change in Knee extensor isokinetic muscle fatigability index at 12 weeks
Description
Knee extensor muscle fatigability will be assessed using a protocol consisting of 30 repetitions or to failure, whichever comes first, at their maximum strength
Time Frame
Baseline, Week 12
Title
Change in Muscle blood flow at 12 weeks
Description
Blood flow will be assessed using Doppler ultrasound
Time Frame
Baseline, Week 12
Title
Change in Isokinetic and isometric peak knee extension force at 12 weeks
Description
Unilateral peak knee extension/flexion isokinetic force (at 180º/s and 60º/s) will be obtained across five continuous repetitions using a load cell
Time Frame
Baseline, Week 6, Week 12
Title
Change in Short Physical Performance Battery at 12 weeks
Description
This composite score is made up of measures of balance, gait speed (15 ft), and timed chair stands (x5).
Time Frame
Baseline, Week 12
Title
Change in Timed Up-and-Go at 12 weeks
Description
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
Time Frame
Baseline, Week 12
Title
Change in Lean Body Mass, as estimated by diagnostic ultrasound at 12 weeks
Description
Sonographic estimates of LBM (aggregate muscle thickness, cm) will serve as a proxy measure for muscle tissue composition in this study
Time Frame
Baseline, Week 6, Week 12
Title
Change in myosteatosis, as estimated by diagnostic ultrasound at 12 weeks
Description
Sonographic estimates of myosteatosis (grayscale, or GSL, values, 0-255) will serve as a proxy measure for muscle tissue composition in this study
Time Frame
Baseline, Week 6, Week 12
Secondary Outcome Measure Information:
Title
Change in Grip strength at 12 weeks
Description
This measure will be obtained with a hand grip dynamometer using the mean value of 3 trials under standardized conditions.
Time Frame
Baseline, Week 12
Title
Change in Activities-Specific Balance Confidence (ABC) Scale at 12 weeks
Description
mobility questionnaire; range 0-100, with higher values indicating higher confidence
Time Frame
Baseline, Week 12
Title
Change in Short Form Health Survey (SF-36) Scale at 12 weeks
Description
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.
Time Frame
Baseline, Week 12
Title
Change in Falls Efficacy Scale (FES) at 12 weeks
Description
fall avoidance behavior questionnaire; range 10-100, with lower values indicating greater efficacy
Time Frame
Baseline, Week 12
Title
Change in weight at 12 weeks
Description
Weight (in lbs) using bioelectric scale
Time Frame
Baseline, Week 6, Week 12
Title
Change in height at 12 weeks
Description
Height (in inches) using stadiometer
Time Frame
Baseline, Week 6, Week 12
Title
Change in body water at 12 weeks
Description
Body water (%) using bioelectric scale
Time Frame
Baseline, Week 6, Week 12
Title
Change in Blood Pressure at 12 weeks
Description
After sitting quietly for 5 minutes, resting blood pressure will be recorded in triplicate
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jared M Gollie, PhD
Phone
202-745-8000
Ext
55851
Email
Jared.Gollie@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Brian M Hoover, MS
Phone
202-745-8000
Ext
55826
Email
Brian.Hoover@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael O Harris-Love, DSc
Organizational Affiliation
Washington DC VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington DC VA Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jared M Gollie, PhD
Phone
202-745-8000
Ext
55851
Email
Jared.Gollie@va.gov
First Name & Middle Initial & Last Name & Degree
Brian M Hoover, MS
Phone
202-745-8000
Ext
55826
Email
Brian.Hoover@va.gov
First Name & Middle Initial & Last Name & Degree
Michael O Harris-Love, DSc
12. IPD Sharing Statement
Plan to Share IPD
No
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Flywheel Exercise for CKD
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