Renal failure Urological and Genital Diseases
Conditions
Interventions
Patients expected to start dialysis within the next 12 months will be invited to take part. Patients who agree to take part will be asked to sign a consent form. All participants attend an initial ass
Sponsors
Derby Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 years and above 2. eGFR less than 15mls/min 3. Rate of change in eGFR indicates that dialysis will be initiated within 12 months from commencing the study 4. Attending the low clearance clinic 5. Patient has opted for dialysis 6. Patient is able to exercise
Exclusion criteria
Exclusion criteria: 1. Patient is not predicted to require dialysis within 12 months of commencing the study 2. Patient has chosen conservative care rather than opting for dialysis 3. Severe physical impairment and/or significant comorbidity that makes exercise impossible or unsafe, defined by exercise-induced angina, inability to walk less than 50 metres, or dyspnoea with effort 4. Insufficient command of English to provide informed consent or comply with the testing protocol and exercise and education component (if results indicate the intervention to be beneficial, future studies will include provision for such patients) 5. Patient is pregnant (therefore is unable to undergo Dual X-Ray Absorption (DEXA) Scan)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional and exercise capacity, determined by the Incremental Shuttle Walk Test; Timepoint(s): End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective changes in functional capacity, determined by increased muscle mass, strength and function, will be assessed using the short physical performance battery test, single repetition maximum for leg extension and bicep curl, and one minute sit to stand, will be measured at baseline, 3 months, upon starting dialysis, and at 3, 6 and 12 months after starting dialysis 2. Objective and subjective changes in nutritional status will be measured using a combination of validated methods, including weight, body mass index (BMI) and percentage weight change, mid upper arm circumference, handgrip strength, dietary intake and appetite assessment, and subjective global assessment of nutritional status will be assessed at baseline, 3 months, upon starting dialysis, and at 3, 6 and 12 months after starting dialysis 3. Subjective changes in functional and exercise capacity, determined by patient perception of functional capacity using the Duke Activity Status Index (DASI) questionnaire, and exercise self-efficacy score will be measured at baseline, 3 months, upon starting dialysis, and at 3, 6 and 12 months after starting dialysis 4. Subjective improvement in quality of life, determined by DASI questionnaire, Patient Activation Measure, Renal Distress Thermometer, FACIT-Fatigue Score, Hospital Anxiety and Depression Scale (HADS), and nested qualitative interview studies will be measured at baseline, 3 months, upon starting dialysis, and at 3, 6 and 12 months after starting dialysis 5. Changes in body composition will be measured using DEXA scans and muscle ultrasound scans at baseline, 3 months, upon starting dialysis, and at 3, 6 and 12 months after starting dialysis 6. The presence of oxidative stress and assessment of cardiovascular risk will be measured from levels of advanced glycation end products (AGEs) via skin autofluorescence at baseline, 3 months, upon starting dialysis, and at 3, 6 a | — |
Countries
United Kingdom
Outcome results
None listed