The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients

Vanderbilt University

Status and phase: Completed; Phase 2

Conditions: End Stage Renal Disease

Treatments: Drug: nutritional supplementation; Behavioral: exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00179140

20064

R01DK045604 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

1

No Intervention group

Description:

control period

2

Active Comparator group

Description:

protein supplementation plus resistance exercise

Treatment:

Drug: nutritional supplementation

3

Active Comparator group

Description:

protein supplementation only

Treatment:

Behavioral: exercise

Drug: nutritional supplementation