- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00018317
Resistance Training and Diet in Patients With Chronic Renal Failure
January 20, 2009 updated by: US Department of Veterans Affairs
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Central Arkansas Veterans Healthcare System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Dinesh Chatoth, M.D.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2000
Study Completion
December 1, 2005
Study Registration Dates
First Submitted
July 3, 2001
First Submitted That Met QC Criteria
July 4, 2001
First Posted (Estimate)
July 5, 2001
Study Record Updates
Last Update Posted (Estimate)
January 21, 2009
Last Update Submitted That Met QC Criteria
January 20, 2009
Last Verified
December 1, 2004
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGCG-005-99F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Kidney Failure, Chronic
-
Centre Hospitalier Universitaire DijonTerminatedEnd-stage Chronic Kidney FailureFrance
-
Baxter Healthcare CorporationRecruitingAcute Kidney Failure | Chronic Kidney FailureChina
-
Angiodynamics, Inc.TerminatedChronic Kidney Disease | Acute Kidney Injury | Acute Renal Failure | Renal Failure Chronic Contrast InducedUnited States
-
Texas A&M UniversityWithdrawnChronic Kidney FailureUnited States
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and... and other collaboratorsRecruitingChronic Kidney Diseases | Acute Renal Failure | Acute Renal Injury | Acute Kidney Failure | Chronic Renal Insufficiency | Kidney Failure, Acute | Renal Insufficiency, Acute | Acute Renal Insufficiency | Acute Kidney Insufficiency | Renal Failure, Acute | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney... and other conditionsUnited States
-
Hopital Jean MinjozUnknownCardiac Surgical Procedures | Preoperative KIDNEY FAILURE, CHRONIC | Postoperative KIDNEY FAILURE, ACUTEFrance
-
Nantes University HospitalNot yet recruiting
-
Ozge AKBABAAtatürk UniversityCompletedChronic Kidney FailureTurkey
-
Chinese PLA General HospitalCompletedKidney Failure,ChronicChina
-
Fatma Alzahraa Mohamed Ibrahim Hassan HaggagUnknown
Clinical Trials on resistance training
-
University of KasselCompleted
-
University of KasselUniversity of PotsdamCompleted
-
University of Alabama at BirminghamCompletedMusculoskeletal and Metabolic CrosstalkUnited States
-
University of Applied Sciences of Western SwitzerlandCompleted
-
University of BarcelonaCompleted
-
Universidade Federal do Triangulo MineiroUnknown
-
Vienna Hospital AssociationRecruiting
-
Universidade Federal de Sao CarlosConselho Nacional de Desenvolvimento Científico e TecnológicoCompletedChronic Obstructive Pulmonary DiseaseBrazil
-
Riphah International UniversityCompletedSports Physical Therapy | Anthropometric Measurements and Elastic Resistance TrainingPakistan
-
Hong Kong Metropolitan UniversityRecruitingFrailty | Mood | Cognition | Mobility | SacropeniaHong Kong