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The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179218
First Posted: September 15, 2005
Last Update Posted: July 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vanderbilt University
September 13, 2005
September 15, 2005
July 9, 2009
April 2005
January 2007   (Final data collection date for primary outcome measure)
increase in lean body mass [ Time Frame: 12 months ]
increase in lean body mass
Complete list of historical versions of study NCT00179218 on ClinicalTrials.gov Archive Site
increase in physical functioning [ Time Frame: 12 months ]
increase in physical functioning
Not Provided
Not Provided
 
The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients
The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
End Stage Renal Disease
  • 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
  • Active Comparator: 1
    only protein supplementation
    Intervention: Drug: nutritional supplementation
  • Active Comparator: 2
    protein supplementation plus exercise
    Interventions:
    • Drug: nutritional supplementation
    • Behavioral: exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
January 2007
January 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00179218
50149
R01DK045604 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Alp Ikizler, MD, Vanderbilt University Medical Center
Vanderbilt University
Not Provided
Principal Investigator: Alp Ikizler, MD Vanderbilt University Medical Center
Vanderbilt University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP