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CompletedNCT00179179Updated Jul 9, 2009

The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

A Phase 2 interventional study of nutritional supplementation and exercise in End Stage Renal Disease, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-07-09.

Sponsored by Vanderbilt University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
11
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • End Stage Renal Disease
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 11 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Active comparator
    1

    nutritional supplement plus resistance exercise

    Drug: nutritional supplementation · Behavioral: exercise

  • Active comparator
    2

    nutritional supplement only (resistance exercise will not be performed)

    Drug: nutritional supplementation

Interventions

  • Drugnutritional 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

  • Behavioralexercise

    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

06

What researchers measure

Primary outcomes

  1. improvement in net protein muscle balance

    Time frame: 10 hours

Secondary outcomes

  1. improvement in net whole body protein balance

    Time frame: 10 hours

07

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00179179
Lead sponsor
Vanderbilt University
First posted
Sep 15, 2005
Start date
Apr 2005
Primary completion
May 2007
Completion
May 2007
Last update
Jul 9, 2009

Study contacts

Alp Ikizler, MD
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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