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Effects of Aerobic Training in End Stage Renal Disease Patients

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Federal University of Juiz de Fora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Exercise Tolerance, Physical Endurance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Juiz de Fora-Núcleo Interdisciplinar de Estudos e Pesquisas em Nefrologia (NIEPEN)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise training

Control

Arm Description

Patients included in the exercise group were submitted to intra-dialytic exercise training, 3 times per week for 12 weeks.

Patients allocated to the control group remained in regular dialysis treatment during the same timeframe.

Outcomes

Primary Outcome Measures

Effects of aerobic training during hemodialysis on exercise tolerance and VO2 kinetics in end stage renal disease patients
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.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2010
Last Updated
November 3, 2010
Sponsor
Federal University of Juiz de Fora
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1. Study Identification

Unique Protocol Identification Number
NCT01234688
Brief Title
Effects of Aerobic Training in End Stage Renal Disease Patients
Official Title
Effects of Aerobic Training During Hemodialysis on Exercise Tolerance in End Stage Renal Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of Juiz de Fora

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Exercise Tolerance, Physical Endurance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training
Arm Type
Experimental
Arm Description
Patients included in the exercise group were submitted to intra-dialytic exercise training, 3 times per week for 12 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients allocated to the control group remained in regular dialysis treatment during the same timeframe.
Intervention Type
Other
Intervention Name(s)
Exercise training
Other Intervention Name(s)
Exercise group
Intervention Description
Patients included in the exercise group were submitted to intra-dialytic exercise training, 3 times per week for 12 weeks.
Primary Outcome Measure Information:
Title
Effects of aerobic training during hemodialysis on exercise tolerance and VO2 kinetics in end stage renal disease patients
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maycon M Reboredo, DSc
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rogério B de Paula, DSc
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Juiz de Fora-Núcleo Interdisciplinar de Estudos e Pesquisas em Nefrologia (NIEPEN)
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36036-330
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
35018639
Citation
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
Results Reference
derived
PubMed Identifier
25038079
Citation
Reboredo MM, Neder JA, Pinheiro BV, Henrique DM, Lovisi JC, Paula RB. Intra-dialytic training accelerates oxygen uptake kinetics in hemodialysis patients. Eur J Prev Cardiol. 2015 Jul;22(7):912-9. doi: 10.1177/2047487314543079. Epub 2014 Jul 18.
Results Reference
derived
PubMed Identifier
22133251
Citation
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.
Results Reference
derived

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Effects of Aerobic Training in End Stage Renal Disease Patients

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