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| Sponsor: | Tufts University |
|---|---|
| Collaborator: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Information provided by: | Tufts University |
| 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 |
| 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 |
| 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
|
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:
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University | |
| Boston, Massachusetts, United States, 02111 | |
| Principal Investigator: | Carmen Castaneda-Sceppa, MD, PhD | Tufts University |
More Information
| 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 |
|
End stage renal disease Maintenance dialysis Resistance exercise Muscle wasting Disability |
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |