Resistance Training During Maintenance Dialysis

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Behavioral: Resistance exercise

• Registration Number: NCT00363961
• Lead Sponsor: Tufts University

Brief Summary

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

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

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-10
• Study First Posted: 2006-08-15
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-09
• Last Update Posted: 2009-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Resistance exercise	resistance exercise
2	Resistance exercise	flexibility exercises

Primary Outcome Measures

Name	Time	Method
- Physical function (short physical performance battery)	6 months

Secondary Outcome Measures

Name	Time	Method
Muscle mass, inflammation biomarkers, quality of life(SF36), and Activities of Daily Living	6 months

Trial Locations

Locations (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University; 🇺🇸 Boston, Massachusetts, United States