The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2006-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

control period

Group Type NO_INTERVENTION

No interventions assigned to this group

2

protein supplementation plus resistance exercise

Group Type ACTIVE_COMPARATOR

nutritional supplementation

Intervention Type DRUG

oral administration of protein supplement (Nepro) during hemodialysis; every other day, 3 days per week for 6 months; Nepro is a lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat

3

protein supplementation only

Group Type ACTIVE_COMPARATOR

nutritional supplementation

Intervention Type DRUG

oral administration of protein supplement (Nepro) during hemodialysis; every other day, 3 days per week for 6 months; Nepro is a lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat

exercise

Intervention Type BEHAVIORAL

either before or during hemodialysis, patients will perform a leg press exercise; every other day, 3 days per week, for 6 months

Interventions

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nutritional supplementation

oral administration of protein supplement (Nepro) during hemodialysis; every other day, 3 days per week for 6 months; Nepro is a lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat

Intervention Type DRUG

exercise

either before or during hemodialysis, patients will perform a leg press exercise; every other day, 3 days per week, for 6 months

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No