Plain English Summary
Background and study aims
We are carrying out a study of 130 haemodialysis patients to investigate the effects of 30 minutes of cycling exercise, three times per week during dialysis. Research has shown that exercise outside of a dialysis session can significantly improve fitness and heart function. However, exercise whilst on dialysis has a number of potential effects on the heart and so the long term consequences of this need to be studied. The aim of this study is therefore to monitor the immediate and long term effects of exercise on dialysis on patients heart and quality of life. The study's findings should help to improve the well-being of future haemodialysis patients by making exercise more available on dialysis units in the UK.
Who can participate?
The CYCLE-HD study aims to recruit 130 haemodialysis patients from a number of haemodialysis units across the Leicester Renal Network.
What does the study involve?
This study will investigate the effects of a 6 month programme of exercise during dialysis. Patients who dialyse on certain shifts take part in the exercise programme, and those on other shifts carry on as usual, without exercising to compare. Patients chosen to undertake exercise use a specially designed exercise bike for 30 minutes during routine dialysis sessions. Both of these groups are very important to the research study, as this will allow us to measure the effects of doing exercise in comparison to not doing exercise. The exercise and non-exercise shifts are decided randomly and patients are not be able to choose which group they are in. All the people taking part in both the exercise and the control groups undergo a set of assessments at the beginning and the end of the study. These takes place over one or two days depending on patients preference. Some of these assessments are also done in the middle of the study. They include measuring fitness levels, looking at the structure of the heart and how it well it works, daily levels of activity, height and weight, and some questionnaires.
What are the possible benefits and risks of participating?
There are no direct benefits to taking part in this research, although we anticipate that the exercise training sessions will help participants get fitter. We hope that the results of the study will help us design improved treatments for other kidney patients in the future. Our pilot work has shown no evidence of any side effects or adverse event of doing exercise while on dialysis. The main risk is from the use of adenosine during the cardiac MRI scans as patients can get symptoms similar to that of exercise like mild breathlessness, flushing and palpitations. These are very short lived however and patients can choose not to have the adenosine injection if they wish.
Where is the study run from?
The CYCLE-HD study has been set up by the University of Leicester and University Hospitals of Leicester NHS Trust from where it will run.
When is study starting and how long is it expected to run for?
February 2015 to June 2018
Who is funding the study?
National Institute of Health Research (UK)
Who is the main contact?
Dr James Burton
Trial website
Contact information
Type
Public
Primary contact
Dr James Burton
ORCID ID
Contact details
Department of Infection
Immunity and Inflammation
Maurice Shock Medical Sciences Building
University Road
Leicester
LE1 9HN
United Kingdom
+44 (0)116 2584042
dsm12@le.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17951
Study information
Scientific title
A randomised, cluster controlled trial to investigate the effects of a programme of intradialytic exercise on cardiovascular outcomes in haemodialysis patients.
Acronym
CYCLE-HD
Study hypothesis
We hypothesise that an intradialytic program of exercise:
1. Leads to a regression in left ventricular mass
2. Is safe with no increase in either cardiac arrhythmias or cardiac fibrosis
3. Leads to an improvement in cardiovascular indices associated with an increased risk and cardiovascular disease and sudden cardiac death.
Ethics approval
NRES Committee East Midlands - Northampton, 31/10/2014, ref: 14/EM/1190
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders
Intervention
The study will compare six month of cycling exercise during dialysis (intervention group) against normal dialysis care (no intervention). The intervention group will use specially adapted and calibrated exercise bicycles three times a week during dialysis, aiming for 30 minutes continuous cycling at a level perceived by patients as 'somewhat hard'. This is set on an individual basis after an assessment with a trained member of staff and is then adjusted as required to progress training. Our pilot exercise programme has been well tolerated with no adverse symptoms reported in any of the exercising patients. It is accessible to patients of different age, gender, culture and ethnicity.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Reduction in left ventricular mass; Timepoint(s): Measured at baseline and after 6-months of exercise intervention.
Secondary outcome measures
1. Measurements of cardiac structure and function measured using MRI and echocardiography (e.g. left ventricular ejection fraction, blood oxygen delivery)
2. Cardiac rhythm measured using 48 hour ambulatory monitoring
3. Non-invasive cardiac measurements (e.g.blood pressure)
4. Measurements of height, weight, waist circumference and body composition analysis
5. Physical functioning measures including walking and standing tests
6. Objective assessment of habitual physical activity using accelerometry
7. Quality of life and perceived function scores using a variety of validated questionnaires
8. Blood markers of myocardial dysfunction and risk
9. Blood markers of the malnutrition and inflammation
Overall trial start date
01/02/2014
Overall trial end date
31/01/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 130; UK Sample Size: 130; Description: To have 80% power to detect a difference between treatment and control groups of a reduction in LV mass of 15g, with an attrition rate of 10%, 65 patients are required in each group.
Total final enrolment
130
Participant exclusion criteria
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
Recruitment start date
16/03/2015
Recruitment end date
07/03/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leicester
Department of Infection, Immunity and Inflammation
Maurice Shock Medical Sciences Building
University Road
Leicester
LE1 9HN
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Methodology data, including reproducibility of imaging techniques, as will the data on cardiac rhythm will be published within the first 18 months. Baseline cross-sectional data, including cardiac and physical function, will be published around 6 months after recruitment has closed. We anticipate publication of the primary outcome data within 12 months of the end of the trial.
IPD sharing statement
Deidentified individual participant data collected for the study, and a data dictionary defining each field in the set, will be made available to others on specific to request to the chief investigator (Prof. James Burton [dsm12@le.ac.uk]) provided all regulatory and data sharing approvals are obtained after. This request should include a pre-specified analysis plan. These data will be available after publication of the primary study findings. There is no time limit for such requests.
Intention to publish date
31/03/2020
Participant level data
Available on request
Basic results (scientific)
See additional file ISRCTN11299707_BasicResults_20Jan20.pdf
Publication list
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27391774
Publication citations
Additional files
- ISRCTN11299707_BasicResults_20Jan20.pdf Uploaded 20/01/2020