Resistance Training During Maintenance Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00363961
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : December 10, 2009
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Behavioral: Resistance exercise Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Resistance Training During Maintenance Dialysis
Study Start Date : April 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. - Physical function (short physical performance battery) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Muscle mass, inflammation biomarkers, quality of life(SF36), and Activities of Daily Living [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00363961

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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Carmen Castaneda-Sceppa, MD, PhD Tufts University

Responsible Party: Carmen Castaneda Sceppa, Northeastern University Identifier: NCT00363961     History of Changes
Other Study ID Numbers: R03DK064825 ( U.S. NIH Grant/Contract )
R03DK064825 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: December 10, 2009
Last Verified: December 2009

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

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