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Effects of Aerobic Training in End Stage Renal Disease Patients

This study has been completed.
Sponsor:
Information provided by:
Federal University of Juiz de Fora
ClinicalTrials.gov Identifier:
NCT01234688
First received: November 3, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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


Condition Intervention
Kidney Failure, Chronic
 Other: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Aerobic Training During Hemodialysis on Exercise Tolerance in End Stage Renal Disease Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of Juiz de Fora:

Primary Outcome Measures:
  • Effects of aerobic training during hemodialysis on exercise tolerance and VO2 kinetics in end stage renal disease patients [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 28
Study Start Date: June 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Exercise group
No Intervention: Control
Patients allocated to the control group remained in regular dialysis treatment during the same timeframe.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234688

Locations
Brazil
Federal University of Juiz de Fora-Núcleo Interdisciplinar de Estudos e Pesquisas em Nefrologia (NIEPEN)
Juiz de Fora, Minas Gerais, Brazil, 36036-330
Sponsors and Collaborators
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
  More Information

No publications provided by Federal University of Juiz de Fora

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Maycon de Moura Reboredo, DSc, Federal University of Juiz de Fora
ClinicalTrials.gov Identifier: NCT01234688     History of Changes
Other Study ID Numbers: 001
Study First Received: November 3, 2010
Last Updated: November 3, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Juiz de Fora:
Exercise Tolerance
Physical Endurance

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on May 23, 2013