Acute Physiological Response to Exercise in End Stage Renal Disease

NCT03064555 | Completed

• 1 other identifier: Acute Exercise Response, Renal
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Disease

Keywords

Renal; Acute; Exercise; Dialysis; Hemodialysis; End stage renal disease; Aerobic

Outcome Measures

Primary Outcomes (1)

• Gas analysis

  Measurement of O2/CO2 kinetics.

  2 months

Secondary Outcomes (5)

• Echocardiogram

  2 months

• Echocardiogram

  2 months

• Echocardiogram

  2 months

• Blood samples

  2 months

• Non invasive cardiac output measurement (NICOM)

  2 months

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• On hemodialysis for at least 3 months.
• 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.

You may not qualify if:

• 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
• Age 18 years or older.
• Able to complete the CPEX and CLE test.
• Significantly limiting disease or comorbidity which would prevent full participation in exercise testing or illicit an abnormal cardiorespiratory response to exercise.
• Chronic kidney disease.

Sponsors & Collaborators

• Coventry University: lead

Study Sites (1)

UHCW

Coventry, Warwickshire, CV1 3LN, United Kingdom

Location

Related 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. No abstract available.

  PMID: 20585013 BACKGROUND

• 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.

  PMID: 24899042 BACKGROUND

• 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.

  PMID: 6482181 BACKGROUND

• 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.

  PMID: 27127638 BACKGROUND

• 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.

  PMID: 24700875 BACKGROUND

• 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.

  PMID: 26275117 BACKGROUND

• 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.

  PMID: 17298212 BACKGROUND

• 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.

  PMID: 26746396 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma from whole blood samples.

MeSH Terms

Conditions

Kidney Diseases; Motor Activity; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavior; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Elizabeth Elizabeth

  Coventry University

  STUDY DIRECTOR

• Prof Derek Renshaw

  Coventry University

  PRINCIPAL INVESTIGATOR

• Prof Alfonso Jimenez

  Coventry University

  PRINCIPAL INVESTIGATOR

• Prof Nithya Krishnan

  Coventry University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Exercise Physiologist (PhD)

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: February 27, 2017
• Study Start: June 13, 2017
• Primary Completion: January 31, 2019
• Study Completion: September 23, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)