Resistance Training and Diet in Patients With Chronic Renal Failure
Primary Purpose
Kidney Failure, Chronic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
low protein diet
resistance training
combination of diet control and exercise
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Diet, exercise
Eligibility Criteria
Men and women 50-89 years with chronic renal failure (defined as creatinine clearance of 25-65). Volunteers must be able to fulfill the requirements associated with this protocol. Volunteers may be hypertensive and/or diabetic.
Sites / Locations
- Central Arkansas Veterans Healthcare System
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00018317
First Posted
July 3, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00018317
Brief Title
Resistance Training and Diet in Patients With Chronic Renal Failure
Official Title
Resistance Training and Diet in Patients With Chronic Renal Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
This study will examine the effects of long-term adherence to a low protein diet (LPD) of 0.6 g/kg-1/d-1 with and without progressive resistance exercise training in patients with impaired renal function on body composition, renal function (glomerular filtration rate), nitrogen balance, muscle strength and size, and functional capacity. The hypothesis is that adherence to a LPD will result in a reduction in skeletal muscle mass and reduced strength and functional capacity while those patients who adhere to the LPD and exercise will demonstrate a similar preservation of renal function but will have greater fat free mass, muscle mass and strength. The intervention trial will last 18 months in which patients with moderate renal failure will be randomly assigned to one of 4 interventions: standard care, standard care + exercise, LPD, and LPD with exercise. In this way the independent and combined effects of diet and exercise on the progression of renal disease and body composition will be monitored. This study will have important implications for the treatment of patients with chronic renal failure. New strategies of combining exercise with recommendations of a low protein diet may slow the progression of renal disease and improve strength and functional capacity in these at-risk patients.
Detailed Description
Management of dietary protein intake of the CRF patient represents a critical balance between providing adequate protein to meet nutritional requirements, and limiting protein intake in the hope of slowing or abating the progression of CRF. A number of studies have demonstrated that reduced dietary protein intake can slow the progression of chronic renal failure. Finding effective ways to increase nitrogen retention and decrease urinary nitrogen excretion may help CRF patients maintain a more positive nitrogen balance and lessen the nitrogen load on the kidneys for a given dietary protein intake. Our laboratory has demonstrated that in older men and women, the consequence of adherence to a low protein diet is an accommodation that results in decreased muscle mass, strength,and compromised immune function. We have also demonstrated that when healthy, free living older men and women consume a weight maintenance diet providing the RDA for protein of 0.8 g/kg-1/day-1 for 15 weeks they lose skeletal muscle mass. These data clearly indicate that elderly people have an increased need for dietary protein (compared to young people). Data has also demonstrated that progressive resistance exercise improves nitrogen balance in older healthy individuals as well as in patients with mild to moderate chronic renal failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Diet, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
low protein diet
Intervention Type
Behavioral
Intervention Name(s)
resistance training
Intervention Type
Behavioral
Intervention Name(s)
combination of diet control and exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Men and women 50-89 years with chronic renal failure (defined as creatinine clearance of 25-65).
Volunteers must be able to fulfill the requirements associated with this protocol.
Volunteers may be hypertensive and/or diabetic.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dinesh Chatoth, M.D.
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
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Resistance Training and Diet in Patients With Chronic Renal Failure
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