The Effects of Resistance Exercise and Protein Supplementation 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

NCT00179218

50149

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: 19 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 ≥ 1.2).
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

1

Active Comparator group

Description:

only protein supplementation

Treatment:

Drug: nutritional supplementation

2

Active Comparator group

Description:

protein supplementation plus exercise

Treatment:

Behavioral: exercise

Drug: nutritional supplementation