End Stage Renal Disease
Conditions
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.
Interventions
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
BEHAVIORALexercise
either before or during hemodialysis, patients will perform a leg press exercise; every other day, 3 days per week, for 6 months
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| increase in lean body mass | 13 months |
Secondary
| Measure | Time frame |
|---|---|
| improve physical functioning | 13 months |
Countries
United States
Outcome results
None listed