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The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179179
First received: September 13, 2005
Last updated: July 8, 2009
Last verified: July 2009
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • improvement in net protein muscle balance [ Time Frame: 10 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improvement in net whole body protein balance [ Time Frame: 10 hours ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: April 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
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 > 1.2).
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00179179     History of Changes
Other Study ID Numbers: 50189, R01 DK 45604
Study First Received: September 13, 2005
Last Updated: July 8, 2009
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 19, 2013