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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

August 10, 2006
December 9, 2009
April 2004
August 2007   (final data collection date for primary outcome measure)
- Physical function (short physical performance battery) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Physical function (short physical performance battery)
Complete list of historical versions of study NCT00363961 on ClinicalTrials.gov Archive Site
Muscle mass, inflammation biomarkers, quality of life(SF36), and Activities of Daily Living [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Muscle mass, inflammation biomarkers, quality of life(SF36), and Activities of Daily Living
Not Provided
Not Provided
 
Resistance Training During Maintenance Dialysis
Resistance Training During Maintenance Dialysis

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
End Stage Renal Disease
Behavioral: Resistance exercise
resistance exercise vs sham comparison
Other Name: strength training
  • Experimental: 1
    resistance exercise
    Intervention: Behavioral: Resistance exercise
  • Sham Comparator: 2
    flexibility exercises
    Intervention: Behavioral: Resistance exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00363961
R03-DK064825, R03-DK064825
Yes
Carmen Castaneda Sceppa, Northeastern University
Tufts University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Carmen Castaneda-Sceppa, MD, PhD Tufts University
Tufts University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP