Effects of Aerobic Training in End Stage Renal Disease Patients

November 3, 2010 updated by: Federal University of Juiz de Fora

Effects of Aerobic Training During Hemodialysis on Exercise Tolerance in End Stage Renal Disease Patients

The investigators raised the hypothesis that exercise training would be associated with improvement in exercise tolerance and VO2 kinetics in hemodialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

End-stage renal disease (ESRD) is associated with several hemodynamic and peripheral muscle abnormalities which could slow the kinetics of O2 uptake(VO2)and diminished tolerance to incremental exercise. Although previous studies have shown that aerobic training is able to accelerate VO2 kinetics in several disease populations, little is known if these positive findings are also applicable to hemodialysis patients.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36036-330
        • Federal University of Juiz de Fora-Núcleo Interdisciplinar de Estudos e Pesquisas em Nefrologia (NIEPEN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The sample included end stage renal disease patients undergoing hemodialysis, three times per week totaling 12h weekly, for at least 6 months in the Nephrology Unit at the University Hospital of the Federal University of Juiz de Fora, State of Minas Gerais, Brazil. No patient had been involved in any kind of exercise training in the preceding 6 months

Exclusion Criteria:

  • unstable angina;
  • uncontrolled arrhythmia;
  • uncompensated heart failure;
  • uncontrolled hypertension (systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 120 mmHg);
  • diabetes mellitus;
  • severe respiratory diseases;
  • acute infection;
  • severe renal osteodystrophy;
  • neurological or musculoskeletal disturbances

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise training
Patients included in the exercise group were submitted to intra-dialytic exercise training, 3 times per week for 12 weeks.
Other: Exercise training
Patients included in the exercise group were submitted to intra-dialytic exercise training, 3 times per week for 12 weeks.
Other Names:
  • Exercise group
No Intervention: Control
Patients allocated to the control group remained in regular dialysis treatment during the same timeframe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of aerobic training during hemodialysis on exercise tolerance and VO2 kinetics in end stage renal disease patients
Time Frame: 3 months
Before and after the intervention or control periods, the participants were submitted to an incremental work rate test and, two days apart, to a constant work rate test to the limit of tolerance.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Juiz de Fora

Investigators

  • Principal Investigator: Maycon M Reboredo, DSc, Federal University of Juiz de Fora
  • Study Director: Rogério B de Paula, DSc, Federal University of Juiz de Fora

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Estimate)

November 4, 2010

Last Update Submitted That Met QC Criteria

November 3, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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