Back to resultsThe Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients
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 years old. Exclusion Criteria: Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc., as determined by the PI and the primary physician of the subject. Pregnant women. Patients hospitalized within the last month prior to the study.
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
only protein supplementation
protein supplementation plus exercise
Outcomes
Primary Outcome Measures
increase in lean body mass
Secondary Outcome Measures
increase in physical functioning
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00179218
Brief Title
The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients
Official Title
The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to determine how protein supplementation, with or without exercise, affects functional capacity, strength, body composition, and physical activity in hemodialysis patients.
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
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
only protein supplementation
Arm Title
2
Arm Type
Active Comparator
Arm Description
protein supplementation plus exercise
Intervention Type
Drug
Intervention Name(s)
nutritional supplementation
Intervention Description
oral administration of 2 cans of protein supplement (lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat); every other day, 3 days per week, for 6 months
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
leg press exercise; every other day, 3 days per week, for 6 months
Primary Outcome Measure Information:
Title
increase in lean body mass
Time Frame
12 months
Secondary Outcome Measure Information:
Title
increase in physical functioning
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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 years old.
Exclusion Criteria:
Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc., as determined by the PI and the primary physician of the subject.
Pregnant women.
Patients hospitalized within the last month prior to the study.
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 Resistance Exercise and Protein Supplementation in Hemodialysis Patients
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