Back to resultsThe Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
nutritional supplementation
exercise
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
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.
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
nutritional supplement plus resistance exercise
nutritional supplement only (resistance exercise will not be performed)
Outcomes
Primary Outcome Measures
improvement in net protein muscle balance
Secondary Outcome Measures
improvement in net whole body protein balance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00179179
Brief Title
The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis
Official Title
The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To test the hypothesis that an exercise session combined with adequate nutritional supplementation improves skeletal muscle protein accretion during a hemodialysis session.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
nutritional supplement plus resistance exercise
Arm Title
2
Arm Type
Active Comparator
Arm Description
nutritional supplement only (resistance exercise will not be performed)
Intervention Type
Drug
Intervention Name(s)
nutritional supplementation
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
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 Outcome Measure Information:
Title
improvement in net protein muscle balance
Time Frame
10 hours
Secondary Outcome Measure Information:
Title
improvement in net whole body protein balance
Time Frame
10 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alp Ikizler, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis
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