The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients

Phase 2

Completed

• Conditions: End Stage Renal Disease
• Interventions: Drug: nutritional supplementation; Behavioral: exercise

• Registration Number: NCT00179218
• 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

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-08
• Last Update Posted: 2009-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	nutritional supplementation	protein supplementation plus exercise
2	exercise	protein supplementation plus exercise
1	nutritional supplementation	only protein supplementation

Primary Outcome Measures

Name	Time	Method
increase in lean body mass	12 months

Secondary Outcome Measures

Name	Time	Method
increase in physical functioning	12 months

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States