The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

Phase 2

Completed

• Conditions: End Stage Renal Disease
• Interventions: Drug: nutritional supplementation; Behavioral: exercise

• Registration Number: NCT00179179
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-08
• Last Update Posted: 2009-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	nutritional supplementation	nutritional supplement plus resistance exercise
1	exercise	nutritional supplement plus resistance exercise
2	nutritional supplementation	nutritional supplement only (resistance exercise will not be performed)

Primary Outcome Measures

Name	Time	Method
improvement in net protein muscle balance	10 hours

Secondary Outcome Measures

Name	Time	Method
improvement in net whole body protein balance	10 hours

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States