Kidney Failure, ChronicNCT01234688
Effects of Aerobic Training in End Stage Renal Disease Patients
A study testing Exercise training in people with Kidney Failure, Chronic, run by Federal University of Juiz de Fora at 1 site in Brazil.
Trial summary
The investigators raised the hypothesis that exercise training would be associated with improvement in exercise tolerance and VO2 kinetics in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 9Show fewer
- acute infection;
- severe renal osteodystrophy;
- neurological or musculoskeletal disturbances
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Juiz de Fora-Núcleo Interdisciplinar de Estudos e Pesquisas em Nefrologia (NIEPEN)
Juiz de Fora, Minas Gerais, 36036-330
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Exercise training
- Keywords
- Exercise Tolerance, Physical Endurance
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Also called Exercise group
Patients included in the exercise group were submitted to intra-dialytic exercise training, 3 times per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | Patients included in the exercise group were submitted to intra-dialytic exercise training, 3 times per week for 12 weeks. Receives: Other: Exercise training |
| Control | No intervention | Patients allocated to the control group remained in regular dialysis treatment during the same timeframe. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startJun 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Investigators
- Maycon M Reboredo, DSc, Principal investigator, Federal University of Juiz de ForaRogério B de Paula, DSc, Study director, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234688
- Sponsor's protocol ID
- 001
- Status last verified
- Jul 2010
- First submitted
- 3 Nov 2010
- Last updated
- 4 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35018639Reboredo 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.
PubMed 25038079Reboredo 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.
PubMed 22133251
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Training During Hemodialysis on Exercise Tolerance in End Stage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT01234688
- Acronym / sponsor ID
- 001
- Conditions
- Kidney Failure, Chronic
- Keywords
- Exercise Tolerance, Physical Endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Exercise trainingPatients included in the exercise group were submitted to intra-dialytic exercise training, 3 times per week for 12 weeks. |
| Control | No intervention | –Patients allocated to the control group remained in regular dialysis treatment during the same timeframe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- unstable angina;
- uncontrolled arrhythmia;
- uncompensated heart failure;
- uncontrolled hypertension (systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 120 mmHg);
- diabetes mellitus;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingAlso: Exercise groupPatients included in the exercise group were submitted to intra-dialytic exercise training, 3 times per week for 12 weeks. | Other | Exercise training |
Primary outcome
Effects of aerobic training during hemodialysis on exercise tolerance and VO2 kinetics in end stage renal disease patients
Time frame: 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2010.
- Derived from this study: PubMed 35018639Bernier-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.
- Derived from this study: PubMed 25038079Reboredo 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.
- Derived from this study: PubMed 22133251Reboredo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maycon M Reboredo, DSc principal investigator
Federal University of Juiz de Fora
Rogério B de Paula, DSc study director
Federal University of Juiz de Fora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Kidney Failure, Chronic, run by Federal University of Juiz de Fora at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01234688, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2010.