The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179140
First received: September 13, 2005
Last updated: December 19, 2007
Last verified: December 2007

September 13, 2005
December 19, 2007
November 2002
February 2006   (final data collection date for primary outcome measure)
increase in lean body mass [ Time Frame: 13 months ] [ Designated as safety issue: No ]
increase in lean body mass
Complete list of historical versions of study NCT00179140 on ClinicalTrials.gov Archive Site
improve physical functioning [ Time Frame: 13 months ] [ Designated as safety issue: No ]
improve physical functioning
Not Provided
Not Provided
 
The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients
The Effects of Protein Supplementation and Resistance Exercise 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: Prevention
End Stage Renal Disease
  • 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
  • No Intervention: 1
    control period
  • Active Comparator: 2
    protein supplementation plus resistance exercise
    Intervention: Drug: nutritional supplementation
  • Active Comparator: 3
    protein supplementation only
    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
26
February 2006
February 2006   (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 > 1.4).
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00179140
20064, R01 DK 45604
No
Alp Ikizler, MD, Vanderbilt University Medical Center
Vanderbilt University
Not Provided
Principal Investigator: Alp Ikizler, MD Vanderbilt University
Vanderbilt University
December 2007

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