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 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
BEHAVIORALexercise
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
TREATMENT
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 ≥ 1.2). * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| increase in lean body mass | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| increase in physical functioning | 12 months |
Countries
United States
Outcome results
None listed