Acute Physiological Response to Exercise in End Stage Renal Disease

Renal Disease Clinical Trial

— PRECISE  

Official title:

Acute Physiological Response to Exercise in End Stage Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064555
• Other study ID #: Acute Exercise Response, Renal
• Status: Completed
• Start date: June 13, 2017
• Est. completion date: September 23, 2019

Study information

• Verified date: February 2020
• Source: Coventry University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 23, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Renal Disease

Locations

Country	Name	City	State
United Kingdom	UHCW	Coventry	Warwickshire

Sponsors (1)

Lead Sponsor	Collaborator
Coventry University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

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. Review. — View 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. — View Citation

Cibulka R, Racek J. Metabolic disorders in patients with chronic kidney failure. Physiol Res. 2007;56(6):697-705. Epub 2007 Feb 8. Review. — View 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. Review. — View 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. — View 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. — View 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. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gas analysis	Measurement of O2/CO2 kinetics.	2 months
Secondary	Echocardiogram	Measurement of regional wall motion abnormalities.	2 months
Secondary	Echocardiogram	Measurement of ejection fraction.	2 months
Secondary	Echocardiogram	Measurement of cardiac output.	2 months
Secondary	Blood samples	Investigation of cardiac, inflammatory and hormonal response to exercise.	2 months
Secondary	Non invasive cardiac output measurement (NICOM)	Measurement of cardiac output during exercise,	2 months