Pre-emptive rehabilitation to prevent dialysis-associated morbidity

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
INTERVENTION: 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 assessment appointment, for exercise tests to measure muscle function and exercise ability, scans to measure muscle mass, and to complete questionnaires to assess appetite and quality of life. Participants are then randomly allocated to the treatment group or usual care group. The treatment group involves a 10‐week exercise and education programme. Each session lasts for 2 hours, with an hour of exercise, followed by an education session, which aims to help participants to cope better with dialysis. Participants will be given an individual exercise and care plan to follow. The exercise and education sessions continue once per month until starting dialysis, and for the first 6 months of dialysis. Participants in the usual care group continue with usual clinic appointments and dialysis. The assessments done at the beginning of the study are repeated at several timepoints throughout the study, before and after starting dialysis. By comparing results from these assessments between the groups, we can assess if this treatment is superior to usual care in maintaining independence and quality of life in patients starting dialysis. CONDITION: Specialty: Renal disorders, Primary sub‐specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Renal failure ; Urological and Genital Diseases PRIMARY OUTCOME: Functional and exercise capacity, determined by the Incremental Shuttle Walk Test; Timepoint(s): End of the study SECONDARY OUTCOME: 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 and 12 months after starting dialysis 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
Epistemonikos ID: e3dba29acfd1453047988b6e8058e62b04a1465c
First added on: Aug 24, 2024