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The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

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ClinicalTrials.gov Identifier: NCT00179179
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 9, 2009
Sponsor:
Information provided by:
Vanderbilt University

Brief Summary:
To test the hypothesis that an exercise session combined with adequate nutritional supplementation improves skeletal muscle protein accretion during a hemodialysis session.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: nutritional supplementation Behavioral: exercise Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis
Study Start Date : April 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

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Arm Intervention/treatment
Active Comparator: 1
nutritional supplement plus resistance exercise
Drug: nutritional supplementation
2 oral ingestions per study visit of protein supplement containing a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat; 6 study visits over a 12-month period

Behavioral: exercise
resistance training on a duel leg press consisting of 3 sets of 8-12 repetitions; the first 5 study visits over a 12-month period

Active Comparator: 2
nutritional supplement only (resistance exercise will not be performed)
Drug: nutritional supplementation
2 oral ingestions per study visit of protein supplement containing a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat; 6 study visits over a 12-month period




Primary Outcome Measures :
  1. improvement in net protein muscle balance [ Time Frame: 10 hours ]

Secondary Outcome Measures :
  1. improvement in net whole body protein balance [ Time Frame: 10 hours ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 18-75

Exclusion Criteria:

  • Pregnant women.
  • Patients unable to perform exercise
  • 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 with malfunctioning arterial-venous access (recirculation and/or blood flow < 750 ml/min)
  • Patients receiving steroids and/or other immunosuppressive agents.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179179


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 Medical Center

Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00179179     History of Changes
Other Study ID Numbers: 50189
R01DK045604 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: July 9, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases