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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

November 3, 2010
November 3, 2010
June 2008
June 2010   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
Not Provided
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Effects of Aerobic Training in End Stage Renal Disease Patients
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Failure, Chronic
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
  • Experimental: Exercise training
    Patients included in the exercise group were submitted to intra-dialytic exercise training, 3 times per week for 12 weeks.
    Intervention: Other: Exercise training
  • No Intervention: Control
    Patients allocated to the control group remained in regular dialysis treatment during the same timeframe.
Reboredo MM, Neder JA, Pinheiro BV, Henrique DM, Faria RS, Paula RB. Constant work-rate test to assess the effects of intradialytic aerobic training in mildly impaired patients with end-stage renal disease: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Dec;92(12):2018-24. doi: 10.1016/j.apmr.2011.07.190.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01234688
001
Yes
Maycon de Moura Reboredo, DSc, Federal University of Juiz de Fora
Federal University of Juiz de Fora
Not Provided
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
Federal University of Juiz de Fora
July 2010

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