The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients

This study has been completed.

Sponsor:

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00179218

First received: September 13, 2005

Last updated: July 8, 2009

Last verified: July 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 8, 2009

Start Date ^ICMJE

April 2005

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

increase in lean body mass [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

increase in lean body mass

Change History

Complete list of historical versions of study NCT00179218 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

increase in physical functioning [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

increase in physical functioning

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients

Official Title ^ICMJE

The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

End Stage Renal Disease

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: 1
only protein supplementation

Intervention: Drug: nutritional supplementation
Active Comparator: 2
protein supplementation plus exercise
Interventions:
- Drug: nutritional supplementation
- Behavioral: exercise

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00179218

Other Study ID Numbers ^ICMJE

50149, R01 DK 45604

Has Data Monitoring Committee

Responsible Party

Alp Ikizler, MD, Vanderbilt University Medical Center

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Alp Ikizler, MD

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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