Abstract
Whether or not clinically implementable exercise interventions in haemodialysis patients improve quality of life remains unknown. The 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. We 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. The setting was five dialysis units across the UK from 2015 to 2019. The participants were adult patients with end-stage kidney disease who had been receiving haemodialysis therapy for > 1 year. Participants were randomised to receive usual-care maintenance haemodialysis or usual-care maintenance haemodialysis plus intradialytic exercise training. The 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. We 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 intervention group and control group was 2.4 arbitrary units (95% confidence interval -0.1 to 4.8 arbitrary units; p = 0.055). Participants in the intervention group had poor compliance (49%) and very poor adherence (18%) to the exercise prescription. The cost of delivering the intervention ranged from £463 to £848 per participant per year. The number of participants with harms was similar in the intervention (n = 69) and control (n = 56) groups. Participants could not be blinded to the intervention; however, outcome assessors were blinded to group allocation. On trial completion the primary outcome (Kidney Disease Quality of Life Short Form, version 1.3, physical component summary score) was not statistically improved compared with usual care. The findings suggest that implementation of an intradialytic cycling programme is not an effective intervention to enhance health-related quality of life, as delivered to this cohort of deconditioned patients receiving haemodialysis. The benefits of longer interventions, including progressive resistance training, should be confirmed even if extradialytic delivery is required. Future studies also need to evaluate whether or not there are subgroups of patients who may benefit from this type of intervention, and whether or not there is scope to optimise the exercise intervention to improve compliance and clinical effectiveness. Current Controlled Trials ISRCTN83508514. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 40. See the NIHR Journals Library website for further project information.
Highlights
Parts of this report are reproduced or adapted with permission from Greenwood et al.[1]
The 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
Primary objective The primary objective of this trial was to determine, in comparison with usual care, whether or not usual care augmented by intradialytic exercise training for a period of 6 months improved Kidney Disease Quality of Life Short Form, version 1.3 (KDQoL-SF), physical component summary (PCS) score in stage 5 chronic kidney disease (CKD) patients receiving maintenance HD
Summary
Parts of this report are reproduced or adapted with permission from Greenwood et al.[1]. In CKD stages 2–5, overall QoL was improved with exercise training.[9] Improved scores in the self-reported physical function subscales of the questionnaires appeared to be the main drivers for the overall improvement.[9] Other elements of QoL, such as vitality, social function and general health, did not show a systematic change.[9] Short-term (2–6 months), structured and supervised moderate-intensity aerobic training programmes (mainly cycling) have been reported to induce a systematic and large improvement in cardiorespiratory fitness (VO2 ) peak of 17–50%, with an overall mean difference between treatment and control groups of 5.22 ml/kg/minute Such improvements exceed the clinically important criterion of 1 metabolic equivalent (MET) (3.5 ml/kg/minute). All costs were in Great British pounds; no currency conversions were required
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