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| 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 |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Resistance Training During Maintenance Dialysis |
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | September 2007 |
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| Contact: Carmen Castaneda-Sceppa, MD, PhD | 617-556-3081 | carmen.sceppa@tufts.edu |
| 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 | |
| Principal Investigator: | Carmen Castaneda-Sceppa, MD, PhD | Tufts University |
More Information
| Study ID Numbers: | R03-DK064825, R03-DK064825 |
| Study First Received: | August 10, 2006 |
| Last Updated: | August 10, 2006 |
| ClinicalTrials.gov Identifier: | NCT00363961 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
End stage renal disease Maintenance dialysis Resistance exercise Muscle wasting Disability |
|
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Kidney Diseases Muscular Atrophy Kidney Failure |
|
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |