Chronic kidney disease Urological and Genital Diseases
Conditions
Interventions
STUDY DESIGN: A feasibility randomised controlled trial with a nested qualitative study to explore participants experiences.
ESTIMATED TRIAL DURATION PER PARTICIPANT: 12 months
Sponsors
King's College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Stages 3-4 CKD patients defined by the following criteria: 1.1. GFR 15-60mL/min from local lab CKD-EPI determined eGFR 1.2. Minimum decline= 5mL/min/year over previous 12-24 months, as meausured by linear regression analysis (minimum of 3 measurments of eGFR over 12 months) 2. Male or female 3. Age > 18 years 4. Declining CKD with no likelihood of reversibility
Exclusion criteria
Exclusion criteria: 1. Age < 18 years 2. Pregnancy 3. Have a history of untoward reactions to iodinated contrast media 4. Have a recent history (last six months) episode of acute kidney injury or have sickle cell disease 5. Requires support for ambulation less than 20 meters 6. Psychosis, bi-polar, eating disorders, any other cognitive/neurological related issues 7. Infection or course of antibiotics within the last month 8. Enrolled in supervised exercise training in previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility: 1. Number of participants screened per month, measured using a screening log monthly 2. Number recruited per month, measured using an enrolment log monthly 3. Proportions of eligible people unwilling to participate with reasons given (e.g. live too far away etc), measured using a screening log monthly 4. Number retained per month, measured using an enrolment log monthly 5. Proportion of planned data collection visits that are completed in full length of time for study visits 6. Adherence to planned supervised exercise training schedule (number of sessions attended) of >80%, measured using Trust Database (PiMS) Clinic Attendance Log 7. Completion of unsupervised exercise diaries of >80% | — |
Secondary
| Measure | Time frame |
|---|---|
| KIDNEY FUNCTION measured through blood tests and urine sample at baseline, 6-month and 12-month visits: 1. Measured glomerular filtration rate (mGFR) using chromium-51 labeled ethylenediamine tetraacetic acid (51Cr-EDTA) or Inulin 2. Estimated GFR (eGFR) by CKD-EPI equations; using lab determined serum creatinine and cystatin C 3. Urinary albuminuria (albumin to creatinine ratio) and proteinuria (protein to creatinine ratio) KIDNEY VASCULAR HEALTH measured at baseline and 12-month visits: 1. Contrast enhanced kidney ultrasound at baseline and 12 months 2. Pulse Wave Velocity: arterial stiffness assessed at the systemic region (carotid-femoral PWV) using the Vicorder system (Skidmore Medical Ltd) - equipment already secured 3. Flow mediated dilatation 4. Carotid Intima-Media Thickness (CIMT) 5. Blood pressure 6. Heart rate PHYSICAL FUNCTION OUTCOMES measured at baseline, 6-month and 12-month visits 1. Peak cardiorespiratory fitness: VO2peak determined during an incremental recumbent cycling exercise tolerance protocol using the MetaLyzer 3B cardiopulmonary exercise testing system (Cortex) 2. Habitual physical activity, measured using long form International Physical Activity Questionnaire (IPAQ) and GTX accelerometers 3. Knee muscle strength measured by a Biodex dynamometer (3 times to the left and right leg) BODY COMPOSITION and anthropometric measures, measured at baseline, 6-month and 12-month visits: 1. Body composition by bioelectrical impedance (Fresenius BCM) 2. Waist: hip ratio 3. Body mass (kg) 4. Body height (cm) 5. Body mass index SAFETY measured at baseline, 6-month and 12-month visits: 1. No. of hospital | — |
Countries
United Kingdom
Outcome results
None listed