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Resistance Training During Maintenance Dialysis

NCT ID: NCT00363961

Last Updated: 2009-12-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-08-31

Brief Summary

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There is a rising incidence of kidney failure in the US, with poor outcomes and high cost. End-stage renal disease (ESRD) affects almost 375,000 individuals in the US at a cost of more than $14 billion per year. Despite advances in dialysis and transplantation therapies, kidney failure leads to poor outcomes, poor prognosis and high health care costs. Malnutrition and the underlying systemic inflammatory response developed during the course of chronic kidney disease, worsen during ESRD, and lead to adverse outcomes, increased morbidity and mortality. Muscle wasting, impaired functional capacity and poor quality of life are the most important factors associated with malnutrition and inflammation in renal failure. We have shown in pre dialysis patients with moderate chronic renal insufficiency that the anabolic effects of resistance exercise training result in significant improvements in protein utilization, nutritional status and functional capacity even in the context of anorexia and prescribed low protein diets. Therefore, we propose to develop, test and implement a progressive resistance exercise routine for ESRD patients during the hemodialysis session. By implementing such intervention, we hope to offer a therapeutic strategy that can be incorporated to the standard of care of ESRD patients by working in conjunction with the dialysis unit staff.

Detailed Description

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The hypotheses to be investigated are that, compared to ESRD patients on maintenance dialysis receiving stretches only, the addition of 30-45 min of progressive resistance training during the hemodialysis session will counteract the burden of renal disease and will result in:

1. A feasible and safe exercise modality for ESRD patients.
2. Will contribute to improved nutritional status and reduced systemic inflammation
3. Will result in improved quality of life

Conditions

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End Stage Renal Disease

Keywords

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End stage renal disease Maintenance dialysis Resistance exercise Muscle wasting Disability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

resistance exercise

Group Type EXPERIMENTAL

Resistance exercise

Intervention Type BEHAVIORAL

resistance exercise vs sham comparison

2

flexibility exercises

Group Type SHAM_COMPARATOR

Resistance exercise

Intervention Type BEHAVIORAL

resistance exercise vs sham comparison

Interventions

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Resistance exercise

resistance exercise vs sham comparison

Intervention Type BEHAVIORAL

Other Intervention Names

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strength training

Eligibility Criteria

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Inclusion Criteria

* Male and female ESRD patients over 30 years of age
* ESRD patients undergoing maintenance hemodialysis 3x/wk for at least 3 months
* Willing to be randomized to either study group
* Compliance with at least 80% of the dialysis sessions

Exclusion Criteria

* Unstable cardiovascular disease
* Any uncontrolled chronic condition
* Cardiac surgery, myocardial infarction, joint replacement, or low extremity fracture within the previous 6 months
* Severe cognitive impairment resulting in inability to understand and provide written informed consent form and or follow instructions
* Current resistance training
* Low extremity amputees
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Northeastern University

Principal Investigators

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Carmen Castaneda-Sceppa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

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Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R03DK064825

Identifier Type: NIH

Identifier Source: secondary_id

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R03DK064825

Identifier Type: NIH

Identifier Source: org_study_id

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