The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients - Full Text View

Purpose

The objective of this study is to determine how protein supplementation, with or without exercise, affects functional capacity, strength, body composition, and physical activity in hemodialysis patients.

Condition	Intervention	Phase
End Stage Renal Disease	Drug: nutritional supplementation Behavioral: exercise	Phase II

MedlinePlus related topics:

Dialysis Dietary Supplements Exercise and Physical Fitness Kidney Failure

ChemIDplus related topics:

Lactose Nepro

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Crossover Assignment

Official Title:	The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

increase in lean body mass [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

improve physical functioning [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Enrollment:	26
Study Start Date:	November 2002
Study Completion Date:	February 2006
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention control period
2: Active Comparator protein supplementation plus resistance exercise	Drug: nutritional supplementation oral administration of protein supplement (Nepro) during hemodialysis; every other day, 3 days per week for 6 months; Nepro is a lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat
3: Active Comparator protein supplementation only	Drug: nutritional supplementation oral administration of protein supplement (Nepro) during hemodialysis; every other day, 3 days per week for 6 months; Nepro is a lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat Behavioral: exercise either before or during hemodialysis, patients will perform a leg press exercise; every other day, 3 days per week, for 6 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program;
Adequately dialyzed (Kt/V > 1.4).
Age > 18 years old.
Properly functioning AV Graft

Exclusion Criteria:

Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc.
Pregnant women.
Severe unstable underlying disease besides commonly associated with ESRD. Cardiac patients that are stable will be included.
Patients hospitalized within the last month prior to the study.
Patients will not perform the MRI if contraindication as determined using the VUMC MRI Procedure Screening Form (attached) or prior claustrophobic reaction in an MRI scanner.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179140

Locations


United States, Tennessee
	Vanderbilt University Medical Center
	Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

Investigators


Principal Investigator:	Alp Ikizler, MD	Vanderbilt University

More Information

Responsible Party:	Vanderbilt University Medical Center ( Alp Ikizler, MD )
Study ID Numbers:	20064, R01 DK 45604
First Received:	September 13, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00179140
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Renal Insufficiency

Urologic Diseases

Renal Insufficiency, Chronic

Kidney Failure, Chronic

Kidney Diseases

Kidney Failure

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00179140