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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
History of Changes
  Purpose

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 Intervention Phase
End Stage Renal Disease
 Drug: nutritional supplementation
Behavioral: exercise
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • increase in lean body mass [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improve physical functioning [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: November 2002
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
control period
Active Comparator: 2
protein supplementation plus resistance exercise
 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
Active Comparator: 3
protein supplementation only
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program;
  • Adequately dialyzed (Kt/V > 1.4).
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179140

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
  More Information

No publications provided

Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00179140     History of Changes
Other Study ID Numbers: 20064, R01 DK 45604
Study First Received: September 13, 2005
Last Updated: December 19, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013