Recruiting

Flywheel Exercise

Sponsor:

Washington D.C. Veterans Affairs Medical Center

Code:

NCT03582982

Conditions

Chronic Kidney Disease stage3

Chronic Kidney Disease stage4

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Eccentric overload exercise

Study Details

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

Study ID

NCT03582982

Start date

May 16, 2018

Status verified date

Nov, 2018

Completion date

Feb 1, 2020

Anticipated

Primary completion date

Feb 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Eccentric overload exercise

Interventions

Eccentric overload exercise

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

Primary outcome measure

  • Change in Knee extensor isokinetic muscle fatigability index at 12 weeks [ Time Frame: Baseline, Week 12 ]
  • Change in Muscle blood flow at 12 weeks [ Time Frame: Baseline, Week 12 ]
  • Change in Isokinetic and isometric peak knee extension force at 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
  • Change in Short Physical Performance Battery at 12 weeks [ Time Frame: Baseline, Week 12 ]
  • Change in Timed Up-and-Go at 12 weeks [ Time Frame: Baseline, Week 12 ]
  • Change in Lean Body Mass, as estimated by diagnostic ultrasound at 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]
  • Change in myosteatosis, as estimated by diagnostic ultrasound at 12 weeks [ Time Frame: Baseline, Week 6, Week 12 ]

Central Contacts and Locations

Central contacts

Locations

Washington DC VA Medical Center

Recruiting

Washington, District of Columbia, United States, 20422

Contacts

Principal Investigator:

Michael O Harris-Love, DSc

More Information

Sponsor

Washington D.C. Veterans Affairs Medical Center

Last update posted

Nov 9, 2018

Last verified

Nov, 2018

Keywords

  • resistance exercise
  • muscle fatigue
  • physical function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Washington D.C. Veterans Affairs Medical Center on 2018-11-09.