Resistance Training During Maintenance Dialysis

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

Official Title
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Resistance Training During Maintenance Dialysis

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Behavioral: Resistance exercise


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>resistance exercise | Behavioral: Resistance exercise<br>* resistance exercise vs sham comparison<br>* Other names: strength training;|
| Sham Comparator: 2<br>flexibility exercises | Behavioral: Resistance exercise<br>* resistance exercise vs sham comparison<br>* Other names: strength training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Physical function (short physical performance battery) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass, inflammation biomarkers, quality of life(SF36), and Activities of Daily Living |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End stage renal disease, Maintenance dialysis, Resistance exercise, Muscle wasting, Disability