Clinical trial NCT01234688: 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
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Keywords: Exercise Tolerance
Physical Endurance
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effects of aerobic training during hemodialysis on exercise tolerance and VO2 kinetics in end stage renal disease patients
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Juiz de Fora
country: Brazil
facility: Federal University of Juiz de Fora-Núcleo Interdisciplinar de Estudos e Pesquisas em Nefrologia (NIEPEN)
state: Minas Gerais
Study officials:
affiliation: Federal University of Juiz de Fora
name: Maycon M Reboredo, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Juiz de Fora
name: Rogério B de Paula, DSc
role: STUDY_DIRECTOR
References:
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.
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.
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.