Kidney Transplant; Complications Clinical Trial
— ECSERTOfficial title:
A Pilot Randomised Controlled Trial of the Effects of a Structured, Home-based Exercise Program on Cardiovascular StructurE and Function in Renal Transplant Recipients: The ECSERT Study
NCT number | NCT04123951 |
Other study ID # | 0714 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 30, 2020 |
Est. completion date | June 30, 2024 |
Although patients who have received a kidney transplant have better health than patients on dialysis, heart problems are still the commonest cause of death for kidney transplant recipients. This is because diseases like high blood pressure and diabetes are more common in patients with kidney transplants as well as factors related to having kidney disease itself and the medications transplant recipients have to take to stop them rejecting their transplanted kidney. Exercise is known to help with heart disease in lots of conditions and improves many of the risk factors known to cause heart disease in kidney transplant recipients. This study will investigate whether an individualised, home-based, exercise program improves heart disease in kidney transplant recipients. The study is a randomised controlled trial, with half the patients completing the 12 week exercise programme and the other half continuing with their normal care. The investigators will use detailed MRI scans to assess patient's hearts and blood vessels at the start and end of the study. The investigators will also assess changes in physical function, exercise capacity, blood markers of heart disease, changes in body type and quality of life measures assessed with questionnaires.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age great than 18 years old - Prevalent RTR longer than 1year - Able and willing to give informed consent - Increased cardiometabolic risk, with at least one of: Diabetes mellitus Dyslipidaemia Hypertension History of ischaemic heart disease or cerebrovascular disease Obesity (BMI above 30) Exclusion Criteria: - Unable to undertake exercise due to physical or psychological barriers - Unable to undergo CMR scanning (incompatible implants, claustrophobia, allergy to agents) - Contraindication to exercise training (American College of Sports Medicine guidelines) - Female participants who are pregnant, lactating, or planning pregnancy during the course of the study. - Scheduled elective surgery or other procedures requiring general anaesthesia during the study. - Any other significant disease or disorder (i.e. significant co-morbidity including unstable hypertension, potentially lethal arrhythmia, myocardial infarction within 6 months, unstable angina, active liver disease, uncontrolled diabetes mellitus (HbA1c greater than or equal to 9%), advanced cerebral or peripheral vascular disease) which, in the opinion of the patient's own clinician the Principle Investigator may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. - Inability to give informed consent or comply with testing and training protocol for any reason. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital Leicester NHS Trust | Leicester | Leicestershire |
Lead Sponsor | Collaborator |
---|---|
University of Leicester |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Integrated Palliative care Outcome Scale for Renal (I-POS-Renal)(change) | IPOS-Renal is a short measure (11 questions), combining the most common symptoms renal patients experience plus additional items from IPOS on concerns beyond symptoms, such as information needs, practical issues, family anxiety. IPOS has been validated in a mixed population of those with cancer and non-cancer diagnosis, including renal patients, and shows good content and construct validity, reliability, and responsiveness to change. Each symptom is rated on a scale of 0-4 for how much that symptom effects the participant. 0 is not at all and 4 is severely. Higher total scores indicate more symptom burden. | Baseline and 12 weeks | |
Other | Short Form Health Survey (SF-12)(change) | Categorical questions that assess limitations in role functioning as a result of physical and emotional health. The survey also contains Likert response formats including those that are on a three-point scale (e.g., limited a lot, limited a little, or not limited at all) that assess limitations in physical activity and physical role functioning. A five-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) that assesses pain, and a five-point scale that assesses overall health (excellent, very good, good, fair, and poor) are included. The SF-12 also contains a six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) that assesses mental health, vitality, and social functioning. Two summary scores: mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 | Baseline and 12 weeks | |
Other | Patient Activation Measure (PAM)(Change) | Individuals are asked to complete a short survey and based on their responses, they receive a PAM score (between 0 and 100). The resulting score places the individual at one of four levels of activation, each of which reveals insight into a range of health-related characteristics, including behaviours and outcomes. The four levels of activation are:
Level 1: Individuals tend to be passive and feel overwhelmed by managing their own health. They may not understand their role in the care process. Level 2: Individuals may lack the knowledge and confidence to manage their health. Level 3: Individuals appear to be taking action but may still lack the confidence and skill to support their behaviours. Level 4: Individuals have adopted many of the behaviours needed to support their health but may not be able to maintain them in the face of life stressors. Particulars of the scoring system (and scales) are not disclosed by the license holder |
Baseline and 12 weeks | |
Other | (FACIT-F)(change) | The FACIT-fatigue scale is a 13-item patient-reported measure of fatigue with a 7-day recall period. Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so". To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue | Baseline and 12 weeks | |
Other | Pittsburgh Sleep Quality Index (PSQI)(change) | In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality | Baseline and 12 weeks | |
Primary | Change in Left ventricular mass (g/m) | Measured using multi-parametric cardiac MRI (CMR) | Baseline and 12 weeks | |
Primary | Change in left/right ventricular volumes (ml) | Measured using multi-parametric cardiac MRI (CMR) | Baseline and 12 weeks | |
Primary | Change in ejection fractions (%) | Measured using multi-parametric cardiac MRI (CMR) | Baseline and 12 weeks | |
Primary | Change in native and post-contrast T1 mapping time (ms) | Measured using multi-parametric cardiac MRI (CMR) | Baseline and 12 weeks | |
Primary | Change in Myocardial systolic-strain (%) | Measured using multi-parametric cardiac MRI (CMR) | Baseline and 12 weeks | |
Primary | Change in peak early-diastolic strain rate (%s-1) | Measured using multi-parametric cardiac MRI (CMR) | Baseline and 12 weeks | |
Primary | Change in Aortic pulse wave velocity (m/s) | Measured using multi-parametric cardiac MRI (CMR) | Baseline and 12 weeks | |
Primary | Change in aortic distensibility (mmHg-1×10-3) | Measured using multi-parametric cardiac MRI (CMR) | Baseline and 12 weeks | |
Primary | Change in Myocardial and hepatic triglyceride content (%) | Measured using multi-parametric cardiac MRI (CMR) | Baseline and 12 weeks | |
Secondary | Recruitment Rate | The feasibility of recruitment and interest of patients is an essential component of whether a full trial is feasible. The number of eligible patients and number of consented will be recorded. Monthly recruitment rate and the time taken to recruit 10 (25%), 20 (50%), 30 (75%), and 40 (100%) patients will be recorded. | Post 12 week intervention | |
Secondary | Number of participants lost to follow up | This is the number of participants leaving the trial due to being uncontactable | Post 12 week intervention | |
Secondary | Number of exercise sessions completed per week | This will assess adherence to the intervention | Post 12 week intervention | |
Secondary | Number of participants dropping out of the trial | Otherwise known as the attrition rate | Post 12 week intervention | |
Secondary | Number of adverse events | This is a measure of the trial safety | Post 12 week intervention | |
Secondary | Aerobic Capacity (change) | Measured by cardiopulmonary exercise test which produces V02 (maximal oxygen uptake) in both l/min and ml/kg/min. This is a measure of a participants aerobic capacity. | Baseline, 2 weeks, 4 weeks and 12 weeks | |
Secondary | Timed up and go test (TUAG)(change) | To determine fall risk and measure the progress of balance, sit to stand and walking. Patient sits and then the time taken to stand up and walk 3 meters and return is measured. If a patient took 14 seconds or longer he or she was classified as high-risk for falling | Baseline and 12 weeks | |
Secondary | Habitual Physical Activity (change) | Via accelerometry | Baseline and 12 weeks | |
Secondary | Lower limb strength (change) | Dynamometry | Baseline and 12 weeks | |
Secondary | Upper Limb Strength (change) | Hand grip | Baseline and 12 weeks | |
Secondary | Change in circulation markers of systemic inflammation | Blood Sampling including but not limited to IL-6, CRP, IL-10, TNF-Alpha | Baseline and 12 weeks | |
Secondary | Muscle quality using Ultrasound Imaging (change) | Cross-sectional area (cm2) | Baseline and 12 weeks | |
Secondary | Muscle quality using Ultrasound Imaging (change) | fat thickness (mm) | Baseline and 12 weeks | |
Secondary | Muscle Elasticity (change) | Muscle elasticity will be measures using a MyotonPro device | Baseline and 12 weeks | |
Secondary | Lower limb endurance (change) | Sit to stand 60 test measuring how many 'sit to stands' can be performed in 60 seconds | Baseline and 12 weeks | |
Secondary | Balance (change) | Measured using a 'wii-fit' style board. Better balance is an idicator of falls risk | Baseline and 12 weeks | |
Secondary | Gait speed (change) | Gait speed is measure as the time taken to walk 4 meters. Slower speeds have been linked to higher mortality risk | Baseline and 12 weeks | |
Secondary | Height | Height measured in meters | Baseline | |
Secondary | Weight (change) | Weight measured in kg | Baseline and 12 weeks | |
Secondary | Body fat % (change) | Body fat measured using bio electrical impedance analysis | Baseline and 12 weeks |
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