Resistance Training During Maintenance Dialysis

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00363961
First received: August 10, 2006
Last updated: December 9, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention
End Stage Renal Disease
Behavioral: Resistance exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Resistance Training During Maintenance Dialysis

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • - Physical function (short physical performance battery) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle mass, inflammation biomarkers, quality of life(SF36), and Activities of Daily Living [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: April 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
resistance exercise
Behavioral: Resistance exercise
resistance exercise vs sham comparison
Other Name: strength training
Sham Comparator: 2
flexibility exercises
Behavioral: Resistance exercise
resistance exercise vs sham comparison
Other Name: strength training

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
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00363961

Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Investigators
Principal Investigator: Carmen Castaneda-Sceppa, MD, PhD Tufts University
  More Information

No publications provided

Responsible Party: Carmen Castaneda Sceppa, Northeastern University
ClinicalTrials.gov Identifier: NCT00363961     History of Changes
Other Study ID Numbers: R03-DK064825, R03-DK064825
Study First Received: August 10, 2006
Last Updated: December 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
End stage renal disease
Maintenance dialysis
Resistance exercise
Muscle wasting
Disability

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on August 20, 2014