Back to resultsThe Effects of Protein Supplementation and Resistance Exercise 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 prevention 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 > 1.4). Age > 18 years old. Properly functioning AV Graft Exclusion Criteria: Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc. Pregnant women. 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 will not perform the MRI if contraindication as determined using the VUMC MRI Procedure Screening Form (attached) or prior claustrophobic reaction in an MRI scanner.
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
control period
protein supplementation plus resistance exercise
protein supplementation only
Outcomes
Primary Outcome Measures
increase in lean body mass
Secondary Outcome Measures
improve physical functioning
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00179140
Brief Title
The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients
Official Title
The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
control period
Arm Title
2
Arm Type
Active Comparator
Arm Description
protein supplementation plus resistance exercise
Arm Title
3
Arm Type
Active Comparator
Arm Description
protein supplementation only
Intervention Type
Drug
Intervention Name(s)
nutritional supplementation
Intervention Description
oral administration of protein supplement (Nepro) during hemodialysis; every other day, 3 days per week for 6 months; Nepro is a 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
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
either before or during hemodialysis, patients will perform a 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
13 months
Secondary Outcome Measure Information:
Title
improve physical functioning
Time Frame
13 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 > 1.4).
Age > 18 years old.
Properly functioning AV Graft
Exclusion Criteria:
Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc.
Pregnant women.
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 will not perform the MRI if contraindication as determined using the VUMC MRI Procedure Screening Form (attached) or prior claustrophobic reaction in an MRI scanner.
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
Citations:
PubMed Identifier
35018639
Citation
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
Results Reference
derived
PubMed Identifier
32390133
Citation
Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
Results Reference
derived
Learn more about this trial
The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients
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