The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179218
First received: September 13, 2005
Last updated: July 8, 2009
Last verified: July 2009

September 13, 2005
July 8, 2009
April 2005
January 2007   (final data collection date for primary outcome measure)
increase in lean body mass [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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: 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00179218
50149, R01 DK 45604
No
Alp Ikizler, MD, Vanderbilt University Medical Center
Vanderbilt University
Not Provided
Principal Investigator: Alp Ikizler, MD Vanderbilt University
Vanderbilt University
July 2009

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