The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients

NCT ID: NCT00179218

Last Updated: 2009-07-09

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

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-01-31

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.

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

only protein supplementation

Group Type ACTIVE_COMPARATOR

nutritional supplementation

Intervention Type DRUG

oral administration of 2 cans of protein supplement (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); every other day, 3 days per week, for 6 months

2

protein supplementation plus exercise

Group Type ACTIVE_COMPARATOR

nutritional supplementation

Intervention Type DRUG

oral administration of 2 cans of protein supplement (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); every other day, 3 days per week, for 6 months

exercise

Intervention Type BEHAVIORAL

leg press exercise; every other day, 3 days per week, for 6 months

Interventions

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nutritional supplementation

oral administration of 2 cans of protein supplement (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); every other day, 3 days per week, for 6 months

Intervention Type DRUG

exercise

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 ≥ 1.2).
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Vanderbilt University Medical Center

Principal Investigators

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Alp Ikizler, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK045604

Identifier Type: NIH

Identifier Source: secondary_id

View Link

50149

Identifier Type: -

Identifier Source: org_study_id

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