NCT01234688

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
Last Updated

November 4, 2010

Status Verified

July 1, 2010

Enrollment Period

2 years

First QC Date

November 3, 2010

Last Update Submit

November 3, 2010

Conditions

Keywords

Exercise TolerancePhysical Endurance

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Exercise training

EXPERIMENTAL

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

Other: Exercise training

Control

NO INTERVENTION

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

Interventions

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

Also known as: Exercise group
Exercise training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Juiz de Fora, Minas Gerais, 36036-330, Brazil

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maycon M Reboredo, DSc

    Federal University of Juiz de Fora

    PRINCIPAL INVESTIGATOR
  • Rogério B de Paula, DSc

    Federal University of Juiz de Fora

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2010

First Posted

November 4, 2010

Study Start

June 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

November 4, 2010

Record last verified: 2010-07

Locations