Acute Physiological Response to Exercise in End Stage Renal Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03064555

Acronym

PRECISE

Enrollment

Registered

2017-02-27

Start date

2017-06-13

Completion date

2019-09-23

Last updated

2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Disease

Keywords

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

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Gas analysis	2 months	Measurement of O2/CO2 kinetics.

Secondary

Measure	Time frame	Description
Echocardiogram	2 months	Measurement of regional wall motion abnormalities.
Blood samples	2 months	Investigation of cardiac, inflammatory and hormonal response to exercise.
Non invasive cardiac output measurement (NICOM)	2 months	Measurement of cardiac output during exercise,

Countries

United Kingdom

Outcome results