Acute Physiological Response to Exercise in End Stage Renal Disease
NCT ID: NCT03064555
Last Updated: 2020-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2017-06-13
2019-09-23
Brief Summary
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Detailed Description
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The use of exercise as a therapeutic intervention in ESRD has grown in popularity, and evidence provided by numerous long term studies indicates cardiopulmonary, metabolic and inflammatory system adaptations. Despite these positive findings, the specific mechanisms through which exercise benefits these patients have not yet been fully established. In addition, the extent to which 'normal' physiology is acutely altered by dialysis treatment, and the effect that aerobic exercise may have on this, is unknown.
In patients with ESRD, this study aims to characterise the acute physiological response to exercise under different conditions. In doing so, the study aims to inform the development of guidelines for safe and effective intra-dialytic exercise training.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Participants with end stage renal disease
Cardiopulmonary exercise test
Cardiopulmonary exercise testing will be conducted on an electronically braked cycle ergometer using a ramped protocol with participants being required to pedal until exhaustion.
Constant load exercise test
Constant load exercise will be performed for 30 min on an electronically braked cycle ergometer whilst seated in a dialysis chair. Blood sampling and echocardiogram will be measured throughout.
No interventions assigned to this group
Healthy participants
Cardiopulmonary exercise test
Cardiopulmonary exercise testing will be conducted on an electronically braked cycle ergometer using a ramped protocol with participants being required to pedal until exhaustion.
Constant load exercise test
Constant load exercise will be performed for 30 min on an electronically braked cycle ergometer whilst seated in a dialysis chair. Blood sampling and echocardiogram will be measured throughout.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 4 hours of dialysis 3 times per week.
* Urea reduction rate of at least 65% during the three months before enrolment.
* Age 18 years or older.
* Able to complete the CPEX and CLE test.
* Age 18 years or older.
* Able to complete the CPEX and CLE test.
Exclusion Criteria
* Clinically significant dysrhythmia.
* Uncontrolled intra-dialytic blood pressure (systolic \> 180, diastolic \>95).
* Excessive fluid accumulation between dialysis sessions (\>3 liters).
* Hemoglobin unstable (below 9.0 g/dL).
* Ischemic cardiac event (\<1 month).
* Unable to exercise.
* Morbidly obese (BMI \> 40).
* Clinically significant and still active inflammatory or malignant process.
* Planned kidney transplant during the duration of study.
Healthy participants
* Significantly limiting disease or comorbidity which would prevent full participation in exercise testing or illicit an abnormal cardiorespiratory response to exercise.
* Chronic kidney disease.
18 Years
ALL
Yes
Sponsors
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Coventry University
OTHER
Responsible Party
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Mr Scott McGuire
Clinical Exercise Physiologist (PhD)
Principal Investigators
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Dr Elizabeth Elizabeth
Role: STUDY_DIRECTOR
Coventry University
Prof Derek Renshaw
Role: PRINCIPAL_INVESTIGATOR
Coventry University
Prof Alfonso Jimenez
Role: PRINCIPAL_INVESTIGATOR
Coventry University
Prof Nithya Krishnan
Role: PRINCIPAL_INVESTIGATOR
Coventry University
Locations
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UHCW
Coventry, Warwickshire, United Kingdom
Countries
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References
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Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available.
Gould DW, Graham-Brown MP, Watson EL, Viana JL, Smith AC. Physiological benefits of exercise in pre-dialysis chronic kidney disease. Nephrology (Carlton). 2014 Sep;19(9):519-27. doi: 10.1111/nep.12285.
Kettner A, Goldberg A, Hagberg J, Delmez J, Harter H. Cardiovascular and metabolic responses to submaximal exercise in hemodialysis patients. Kidney Int. 1984 Jul;26(1):66-71. doi: 10.1038/ki.1984.135.
Nelson A, Otto J, Whittle J, Stephens RC, Martin DS, Prowle JR, Ackland GL. Subclinical cardiopulmonary dysfunction in stage 3 chronic kidney disease. Open Heart. 2016 Feb 24;3(1):e000370. doi: 10.1136/openhrt-2015-000370. eCollection 2016.
Viana JL, Kosmadakis GC, Watson EL, Bevington A, Feehally J, Bishop NC, Smith AC. Evidence for anti-inflammatory effects of exercise in CKD. J Am Soc Nephrol. 2014 Sep;25(9):2121-30. doi: 10.1681/ASN.2013070702. Epub 2014 Apr 3.
Peres A, Perotto DL, Dorneles GP, Fuhro MI, Monteiro MB. Effects of intradialytic exercise on systemic cytokine in patients with chronic kidney disease. Ren Fail. 2015 Aug 14:1-5. Online ahead of print.
Cibulka R, Racek J. Metabolic disorders in patients with chronic kidney failure. Physiol Res. 2007;56(6):697-705. doi: 10.33549/physiolres.931128. Epub 2007 Feb 8.
Chapter 1: Introduction and definition of CKD-MBD and the development of the guideline statements. Kidney Int. 2009 Aug;76113:S3-8. doi: 10.1038/ki.2009.189. No abstract available.
Other Identifiers
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Acute Exercise Response, Renal
Identifier Type: -
Identifier Source: org_study_id
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