Improving cardiovascular health in dialysis patients using a structured programme of exercise (CYCLE-HD)
- Conditions
- Topic: Renal disordersSubtopic: Renal disordersDisease: All Renal disordersUrological and Genital Diseases
- Registration Number
- ISRCTN11299707
- Lead Sponsor
- niversity of Leicester (UK)
- Brief Summary
2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27391774 protocol 2021 Results article in https://doi.org/10.1016/j.kint.2021.02.027 Effects on left ventricular mass (added 04/05/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34854982/ Effect of cycling on microparticles or circulating markers of systemic inflammation (added 03/12/2021) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33148767/ Feasibility substudy in frail patients (added 25/07/2022) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34169195/ Cost-effective analysis (added 08/04/2024) 2018 Other publications in https://pubmed.ncbi.nlm.nih.gov/30005636/ Defining myocardial fibrosis in haemodialysis patients with non-contrast cardiac magnetic resonance (added 08/04/2024) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33258084/ The cardiovascular determinants of physical function in patients with end-stage kidney disease on haemodialysis (added 08/04/2024) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32507107/ The reliability and feasibility of non-contrast adenosine stress cardiovascular magnetic resonance T1 mapping in patients on haemodialysis (added 08/04/2024) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/39050864/ Impact of physical activity on surrogate markers of cardiovascular disease (added 29/07/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 130
1. Be a prevalent haemodialysis patient (on haemodialysis for more than 3 months)
2. Age 18 years or older
3. Able and willing to give informed consent
1. Unable to participate in current exercise program due to perceived physical or psychological barriers
2. Unable to undergo MRI scanning (metal implants / prostheses, claustrophobia etc.)
3. Unfit to undertake exercise according to the American College of Sports Medicine guidelines
4. Contraindications to exercise testing (35) that include:
4.1. Recent significant change in resting ECG that suggests significant ischaemia, recent myocardial infarction (2 weeks) or other acute cardiac event;
4.2. Unstable angina;
4.3. Uncontrolled cardiac dysrhythmias causing symptoms or haemodynamic compromise;
4.4. Symptomatic severe aortic stenosis
4.5. Uncontrolled symptomatic heart failure
4.6. Acute pulmonary embolus or pulmonary infarction
4.7. Acute myocarditis or pericarditis
4.8. Suspected or known dissecting aneurysm
4.9. Acute systemic infection, accompanied by fever, body aches or swollen lymph glands
5. Age <18 years
6. Unable or unwilling to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in left ventricular mass; Timepoint(s): Measured at baseline and after 6-months of exercise intervention.
- Secondary Outcome Measures
Name Time Method 1. Measurements of cardiac structure and function measured using MRI and echocardiography (e.g. left ventricular ejection fraction, blood oxygen delivery)<br>2. Cardiac rhythm measured using 48 hour ambulatory monitoring<br>3. Non-invasive cardiac measurements (e.g.blood pressure)<br>4. Measurements of height, weight, waist circumference and body composition analysis<br>5. Physical functioning measures including walking and standing tests<br>6. Objective assessment of habitual physical activity using accelerometry<br>7. Quality of life and perceived function scores using a variety of validated questionnaires<br>8. Blood markers of myocardial dysfunction and risk<br>9. Blood markers of the malnutrition and inflammation