The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

End Stage Renal Disease Clinical Trial

Official title:

The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179179
• Other study ID #: 50189
• Secondary ID: R01DK045604
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: July 8, 2009
• Start date: April 2005
• Est. completion date: May 2007

Study information

• Verified date: July 2009
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in net protein muscle balance		10 hours	No
Secondary	improvement in net whole body protein balance		10 hours	No