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

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00179218

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

Drug Information available for: Lactose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment
Official Title:	The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

increase in lean body mass [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

increase in physical functioning [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	April 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator only protein supplementation	Drug: nutritional supplementation oral administration of 2 cans of protein supplement (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); every other day, 3 days per week, for 6 months
2: Active Comparator protein supplementation plus exercise	Drug: nutritional supplementation oral administration of 2 cans of protein supplement (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); every other day, 3 days per week, for 6 months Behavioral: exercise 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 ≥ 1.2).
Age ≥ 18 years old.

Exclusion Criteria:

Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc., as determined by the PI and the primary physician of the subject.
Pregnant women.
Patients hospitalized within the last month prior to the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179218

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:	50149, R01 DK 45604
Study First Received:	September 13, 2005
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00179218
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 January 14, 2009