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Resistance Training During Maintenance Dialysis

This study is currently recruiting participants.
Verified by Tufts Medical Center, August 2006

Sponsors and Collaborators: Tufts Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00363961
  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

MedlinePlus related topics:   Exercise and Physical Fitness    Kidney Failure   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:   Resistance Training During Maintenance Dialysis

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • - Physical function (short physical performance battery)

Secondary Outcome Measures:
  • Muscle mass, inflammation biomarkers, quality of life(SF36), and Activities of Daily Living

Estimated Enrollment:   40
Study Start Date:   April 2004
Estimated Study Completion Date:   September 2007

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

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

Contacts
Contact: Carmen Castaneda-Sceppa, MD, PhD     617-556-3081     carmen.sceppa@tufts.edu    

Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University     Recruiting
      Boston, Massachusetts, United States, 02111
      Contact: Carmen Castaneda-Sceppa, MD, PhD     617-556-3081     carmen.sceppa@tufts.edu    
      Contact: Charlotte Mallio, BS     617-556-3075     charlotte.mallio@tufts.edu    
      Principal Investigator: Carmen Castaneda-Sceppa, MD, PhD            
      Sub-Investigator: Andrew S. Levey, MD            
      Sub-Investigator: Betrand Jaber, MA            
      Sub-Investigator: Joline Chen, MD, MS            
      Sub-Investigator: Orfeas Liangos, MD            
      Sub-Investigator: Susan Coomber, MS            

Sponsors and Collaborators

Investigators
Principal Investigator:     Carmen Castaneda-Sceppa, MD, PhD     Tufts University    
  More Information


Study ID Numbers:   R03-DK064825, R03-DK064825
First Received:   August 10, 2006
Last Updated:   August 10, 2006
ClinicalTrials.gov Identifier:   NCT00363961
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Muscular Atrophy
Kidney Failure

ClinicalTrials.gov processed this record on October 10, 2008




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