Flywheel Exercise for CKD

NCT ID: NCT03582982

Last Updated: 2018-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-16

Study Completion Date

2020-02-01

Brief Summary

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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

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Conditions

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Chronic Kidney Disease stage3 Chronic Kidney Disease stage4

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Eccentric overload exercise

Group Type EXPERIMENTAL

Eccentric overload exercise

Intervention Type BEHAVIORAL

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

Interventions

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Eccentric overload exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington D.C. Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael O Harris-Love, DSc

Role: PRINCIPAL_INVESTIGATOR

Washington DC VA Medical Center

Locations

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Washington DC VA Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jared M Gollie, PhD

Role: CONTACT

202-745-8000 ext. 55851

Brian M Hoover, MS

Role: CONTACT

202-745-8000 ext. 55826

Facility Contacts

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Jared M Gollie, PhD

Role: primary

202-745-8000 ext. 55851

Brian M Hoover, MS

Role: backup

202-745-8000 ext. 55826

Other Identifiers

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01903

Identifier Type: -

Identifier Source: org_study_id

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