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Clinical Trials/NCT00179179
NCT00179179
Completed
Phase 2

The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

Vanderbilt University1 site in 1 country11 target enrollmentApril 2005

Overview

Phase
Phase 2
Intervention
nutritional supplementation
Conditions
End Stage Renal Disease
Sponsor
Vanderbilt University
Enrollment
11
Locations
1
Primary Endpoint
improvement in net protein muscle balance
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
April 2005
End Date
May 2007
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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.

Arms & Interventions

1

nutritional supplement plus resistance exercise

Intervention: nutritional supplementation

1

nutritional supplement plus resistance exercise

Intervention: exercise

2

nutritional supplement only (resistance exercise will not be performed)

Intervention: nutritional supplementation

Outcomes

Primary Outcomes

improvement in net protein muscle balance

Time Frame: 10 hours

Secondary Outcomes

  • improvement in net whole body protein balance(10 hours)

Study Sites (1)

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