Clinical trial NCT03582982: Flywheel Exercise for CKD
Official title: Flywheel Resistance Exercise to Improve Skeletal Muscle in Veterans With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease stage3
Chronic Kidney Disease stage4
Keywords: resistance exercise
muscle fatigue
physical function
Lead sponsor: Washington D.C. Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2018-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in Knee extensor isokinetic muscle fatigability index at 12 weeks
timeFrame: Baseline, Week 12
measure: Change in Muscle blood flow at 12 weeks
timeFrame: Baseline, Week 12
measure: Change in Isokinetic and isometric peak knee extension force at 12 weeks
timeFrame: Baseline, Week 6, Week 12
measure: Change in Short Physical Performance Battery at 12 weeks
timeFrame: Baseline, Week 12
measure: Change in Timed Up-and-Go at 12 weeks
timeFrame: Baseline, Week 12
measure: Change in Lean Body Mass, as estimated by diagnostic ultrasound at 12 weeks
timeFrame: Baseline, Week 6, Week 12
measure: Change in myosteatosis, as estimated by diagnostic ultrasound at 12 weeks
timeFrame: Baseline, Week 6, Week 12
Secondary outcomes:
measure: Change in Grip strength at 12 weeks
timeFrame: Baseline, Week 12
measure: Change in Activities-Specific Balance Confidence (ABC) Scale at 12 weeks
timeFrame: Baseline, Week 12
measure: Change in Short Form Health Survey (SF-36) Scale at 12 weeks
timeFrame: Baseline, Week 12
measure: Change in Falls Efficacy Scale (FES) at 12 weeks
timeFrame: Baseline, Week 12
measure: Change in weight at 12 weeks
timeFrame: Baseline, Week 6, Week 12
measure: Change in height at 12 weeks
timeFrame: Baseline, Week 6, Week 12
measure: Change in body water at 12 weeks
timeFrame: Baseline, Week 6, Week 12
measure: Change in Blood Pressure at 12 weeks
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
Study officials:
affiliation: Washington DC VA Medical Center
name: Michael O Harris-Love, DSc
role: PRINCIPAL_INVESTIGATOR
References: