Exercise programme to improve quality of life for patients with end-stage kidney disease receiving haemodialysis: the PEDAL RCT

• Published in: Health technology assessment (Winchester, England) England), 2021-06, Vol.25 (40), p.1-52
• Main Authors: Greenwood, Sharlene A, Koufaki, Pelagia, Macdonald, Jamie H, Bulley, Catherine, Bhandari, Sunil, Burton, James O, Dasgupta, Indranil, Farrington, Kenneth, Ford, Ian, Kalra, Philip A, Kumwenda, Mick, Macdougall, Iain C, Messow, Claudia-Martina, Mitra, Sandip, Reid, Chante, Smith, Alice C, Taal, Maarten W, Thomson, Peter C, Wheeler, David C, White, Claire, Yaqoob, Magdi, Mercer, Thomas H
• Format: Article
• Language: English
• Subjects: chronic kidney disease; physical activity; physical function; rehabilitation
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta25400

BACKGROUNDWhether or not clinically implementable exercise interventions in haemodialysis patients improve quality of life remains unknown.OBJECTIVESThe PEDAL (PrEscription of intraDialytic exercise to improve quAlity of Life in patients with chronic kidney disease) trial evaluated the clinical effectiveness and cost-effectiveness of a 6-month intradialytic exercise programme on quality of life compared with usual care for haemodialysis patients.DESIGNWe conducted a prospective, multicentre randomised controlled trial of haemodialysis patients from five haemodialysis centres in the UK and randomly assigned them (1 : 1) using a web-based system to (1) intradialytic exercise training plus usual-care maintenance haemodialysis or (2) usual-care maintenance haemodialysis.SETTINGThe setting was five dialysis units across the UK from 2015 to 2019.PARTICIPANTSThe participants were adult patients with end-stage kidney disease who had been receiving haemodialysis therapy for > 1 year.INTERVENTIONSParticipants were randomised to receive usual-care maintenance haemodialysis or usual-care maintenance haemodialysis plus intradialytic exercise training.MAIN OUTCOME MEASURESThe primary outcome of the study was change in Kidney Disease Quality of Life Short Form, version 1.3, physical component summary score (from baseline to 6 months). Cost-effectiveness was determined using health economic analysis and the EuroQol-5 Dimensions, five-level version. Additional secondary outcomes included quality of life (Kidney Disease Quality of Life Short Form, version 1.3, generic multi-item and burden of kidney disease scales), functional capacity (sit-to-stand 60 and 10-metre Timed Up and Go tests), physiological measures (peak oxygen uptake and arterial stiffness), habitual physical activity levels (measured by the International Physical Activity Questionnaire and Duke Activity Status Index), fear of falling (measured by the Tinetti Falls Efficacy Scale), anthropometric measures (body mass index and waist circumference), clinical measures (including medication use, resting blood pressure, routine biochemistry, hospitalisations) and harms associated with intervention. A nested qualitative study was conducted.RESULTSWe randomised 379 participants; 335 patients completed baseline assessments and 243 patients (intervention, n = 127; control, n = 116) completed 6-month assessments. The mean difference in change in physical component summary score from baseline to 6 months between the inte