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Completed

NCT Number: NCT00179179

The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

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

Completed

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nutritional supplementation

Drug

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

Exercise

Behavioral

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

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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Jul 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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