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The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT00179218
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 9, 2009
Sponsor:
Information provided by:
Vanderbilt University

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients
Study Start Date : April 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
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
Active Comparator: 2
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



Primary Outcome Measures :
  1. increase in lean body mass [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. increase in physical functioning [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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.

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): 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 Medical Center

Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00179218     History of Changes
Other Study ID Numbers: 50149
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