The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients
Phase 2
Completed
- Conditions
- End Stage Renal Disease
- Interventions
- Drug: nutritional supplementationBehavioral: exercise
- Registration Number
- NCT00179140
- Lead Sponsor
- Vanderbilt University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 3 nutritional supplementation protein supplementation only 2 nutritional supplementation protein supplementation plus resistance exercise 3 exercise protein supplementation only
- Primary Outcome Measures
Name Time Method increase in lean body mass 13 months
- Secondary Outcome Measures
Name Time Method improve physical functioning 13 months
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States