The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

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

NCT00179179

50189

R01DK045604 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

To test the hypothesis that an exercise session combined with adequate nutritional supplementation improves skeletal muscle protein accretion during a hemodialysis session.

Enrollment: 11 patients

Sex: All

Ages: 18 to 75 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 18-75

Exclusion criteria

• Pregnant women.
• Patients unable to perform exercise
• 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 with malfunctioning arterial-venous access (recirculation and/or blood flow < 750 ml/min)
• Patients receiving steroids and/or other immunosuppressive agents.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

1

Active Comparator group

Description:

nutritional supplement plus resistance exercise

Treatment:

Drug: nutritional supplementation

Behavioral: exercise

2

Active Comparator group

Description:

nutritional supplement only (resistance exercise will not be performed)

Treatment:

Drug: nutritional supplementation