The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients

Study Overview
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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.

Official Title
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The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Drug: nutritional supplementation
* Behavioral: exercise


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>control period | |
| Active Comparator: 2<br>protein supplementation plus resistance exercise | Drug: nutritional supplementation<br>* 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<br>|
| Active Comparator: 3<br>protein supplementation only | Drug: nutritional supplementation<br>* 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<br>Behavioral: exercise<br>* either before or during hemodialysis, patients will perform a leg press exercise; every other day, 3 days per week, for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in lean body mass |  | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improve physical functioning |  | 13 months |