Clinical trial NCT03064555: Acute Physiological Response to Exercise in End Stage Renal Disease
Official title: Acute Physiological Response to Exercise in End Stage Renal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Disease
Keywords: Renal
Acute
Exercise
Dialysis
Hemodialysis
End stage renal disease
Aerobic
Lead sponsor: Coventry University
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with end stage renal disease:

Patients will be recruited from the University Hospitals Coventry \& Warwickshire hemodialysis unit identified by the research team and renal medical professionals.

Healthy participants:

Healthy participants will be recruited from Coventry University database of previous research participants. This group will comprise of 20 participants, age and weight matched to the patients with ESRD.

Brief summary: Chronic kidney disease (CKD) affects between 5-10% of the world's population, equating to \~740 million people worldwide. End stage renal disease (ESRD) is the result of a progressive loss of kidney function where the patient requires dialysis to replace the typical functions of the kidney. The quality of life of these individuals can be poor as a result of various complications associated with CKD (e.g. heart disease, diabetes, muscle wastage, decreased fitness). In an attempt to combat reduced physical fitness, many studies have applied long term exercise programmes. However, the body's response to exercise in people with CKD is not well understood and a set of guidelines that informs safe and effective exercise prescription is lacking.

Detailed description: Chronic kidney disease (CKD) affects between 5-10% of the world's population, equating to \~740 million people worldwide. End stage renal disease (ESRD) is the result of a progressive loss of kidney function where the patient requires dialysis to replace the typical functions of the kidney. The quality of life (QOL) of these individuals is severely impaired as a result of various complications associated with CKD (e.g. heart disease, diabetes, muscle wastage, decreased fitness). In an attempt to combat this decrease in physical fitness, many studies have applied long term exercise interventions. However, the acute response to exercise in this population is not entirely understood and a comprehensive set of guidelines that informs safe and effective exercise prescription is lacking.

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.

Eligibility criteria: Participants with end stage renal disease

Inclusion criteria

* On hemodialysis for at least 3 months.
* 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.

Exclusion criteria

* Clinically significant valvular insufficiency.
* 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

Inclusion criteria

* Age 18 years or older.
* Able to complete the CPEX and CLE test.

Exclusion criteria

* Significantly limiting disease or comorbidity which would prevent full participation in exercise testing or illicit an abnormal cardiorespiratory response to exercise.
* Chronic kidney disease.

Primary outcomes:
measure: Gas analysis
timeFrame: 2 months
Secondary outcomes:
measure: Echocardiogram
timeFrame: 2 months
measure: Echocardiogram
timeFrame: 2 months
measure: Echocardiogram
timeFrame: 2 months
measure: Blood samples
timeFrame: 2 months
measure: Non invasive cardiac output measurement (NICOM)
timeFrame: 2 months
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: UHCW
state: Warwickshire
Study officials:
affiliation: Coventry University
name: Dr Elizabeth Elizabeth
role: STUDY_DIRECTOR
affiliation: Coventry University
name: Prof Derek Renshaw
role: PRINCIPAL_INVESTIGATOR
affiliation: Coventry University
name: Prof Alfonso Jimenez
role: PRINCIPAL_INVESTIGATOR
affiliation: Coventry University
name: Prof Nithya Krishnan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.