Cardiopulmonary Exercise Testing Parameters' Variability in Hemodialysis Patients.
Greece28 participantsStarted 2021-12-01
Plain-language summary
Chronic kidney disease (CKD), especially end-stage kidney disease (ESKD), is associated with increased risk for cardiovascular events and all-cause mortality. Exercise intolerance as well as reduced cardiovascular reserve are extremely common in patients with CKD. Cardiopulmonary exercise testing (CPET) is a non-invasive, dynamic technique that provides an integrative evaluation of cardiovascular, pulmonary, neuropsychological and metabolic function during maximal or submaximal exercise, allowing the evaluation of functional reserves of these systems. CPET is currently considered to be the gold-standard for identifying exercise limitation and differentiating its causes. It has been widely used in several medical fields for risk stratification, clinical evaluation and other applications. However, the use of CPET in assessment of exercise intolerance in everyday nephrology practice is limited. Hence, this is the first study possible differences in CPET's parameters during long and short interdialytic intervals in hemodialysis patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Hemodialysis patients aged \>18 years.
* Patients with a total duration of hemodialysis \>3 months.
* Patients enrolled in a dialysis program that includes three sessions per week.
* Hemodialysis patients who are capable of exercising on a cycle ergometer.
* Hemodialysis patients who are capable of understanding and providing written, signed consent to participate in the study
Exclusion Criteria:
Absolute and relative contraindications for performing CPET according to the American Thoracic Society (ATS) and the American College of Chest Physicians (ACCP), such as
* Acute myocardial infarction (3-5 days)
* Unstable angina
* Uncontrolled arrhythmias causing symptoms or haemodynamic compromise
* Syncope
* Active endocarditis
* Acute myocarditis or pericarditis
* Symptomatic severe aortic stenosis
* Uncontrolled heart failure
* Acute pulmonary embolus or pulmonary infarction
* Thrombosis of lower extremities
* Suspected dissecting aneurysm
* Uncontrolled asthma
* Pulmonary oedema
* Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (ie, infection, renal failure, thyrotoxicosis)
* Mental impairment leading to inability to cooperate
* Orthopaedic impairment that compromises exercise performance
* Electrolyte abnormalities
* Advanced or complicated pregnancy...
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in VO2peak (ml/min/kg)
Timeframe: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
2
Difference in VO2peak ((ml/min)
Timeframe: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)