Effects of Aerobic Training in End Stage Renal Disease Patients

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234688
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: November 3, 2010
• Last updated: November 3, 2010
• Start date: June 2008
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: Federal University of Juiz de Fora
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Brazil	Federal University of Juiz de Fora-Núcleo Interdisciplinar de Estudos e Pesquisas em Nefrologia (NIEPEN)	Juiz de Fora	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Juiz de Fora

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	No