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Trial record 1 of 53 for:    PRECISE | United Kingdom
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Acute Physiological Response to Exercise in End Stage Renal Disease (PRECISE)

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ClinicalTrials.gov Identifier: NCT03064555
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Mr Scott McGuire, Coventry University

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.

Condition or disease
Renal Disease

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 55 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Months
Official Title: Acute Physiological Response to Exercise in End Stage Renal Disease
Actual Study Start Date : June 13, 2017
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.




Primary Outcome Measures :
  1. Gas analysis [ Time Frame: 2 months ]
    Measurement of O2/CO2 kinetics.


Secondary Outcome Measures :
  1. Echocardiogram [ Time Frame: 2 months ]
    Measurement of regional wall motion abnormalities.

  2. Echocardiogram [ Time Frame: 2 months ]
    Measurement of ejection fraction.

  3. Echocardiogram [ Time Frame: 2 months ]
    Measurement of cardiac output.

  4. Blood samples [ Time Frame: 2 months ]
    Investigation of cardiac, inflammatory and hormonal response to exercise.

  5. Non invasive cardiac output measurement (NICOM) [ Time Frame: 2 months ]
    Measurement of cardiac output during exercise,


Biospecimen Retention:   Samples Without DNA
Serum and plasma from whole blood samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064555


Contacts
Contact: Scott McGuire +447980113721 mcguire9@uni.coventry.ac.uk
Contact: Dr Gordon McGregor +442476 234 570 gordon.mcgregor@uhcw.nhs.uk

Locations
United Kingdom
UHCW Recruiting
Coventry, Warwickshire, United Kingdom, CV1 3LN
Contact: Scott McGuire       mcguire9@uni.coventry.ac.uk   
Sponsors and Collaborators
Coventry University
Investigators
Study Director: Dr Elizabeth Elizabeth Coventry University
Principal Investigator: Prof Derek Renshaw Coventry University
Principal Investigator: Prof Alfonso Jimenez Coventry University
Principal Investigator: Prof Nithya Krishnan Coventry University

Publications of Results:
Other Publications:

Responsible Party: Mr Scott McGuire, Clinical Exercise Physiologist (PhD), Coventry University
ClinicalTrials.gov Identifier: NCT03064555     History of Changes
Other Study ID Numbers: Acute Exercise Response, Renal
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mr Scott McGuire, Coventry University:
Renal
Acute
Exercise
Dialysis
Hemodialysis
End stage renal disease
Aerobic

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency