The PrEscription of intraDialytic exercise to improve quAlity of Life in patients with chronic kidney disease trial: study design and baseline data for a multicentre randomized controlled trial

Greenwood, S. A. et al. (2021) The PrEscription of intraDialytic exercise to improve quAlity of Life in patients with chronic kidney disease trial: study design and baseline data for a multicentre randomized controlled trial. Clinical Kidney Journal, 14(5), pp. 1345-1355. (doi: 10.1093/ckj/sfaa107) (PMID:33959264) (PMCID:PMC8087141)

Abstract

Background: Exercise interventions designed to improve physical function and reduce sedentary behaviour in haemodialysis (HD) patients might improve exercise capacity, reduce fatigue and lead to improved quality of life (QOL). The PrEscription of intraDialytic exercise to improve quAlity of Life study aimed to evaluate the effectiveness of a 6-month intradialytic exercise programme on QOL and physical function, compared with usual care for patients on HD in the UK. Methods: We conducted a prospective, pragmatic multicentre randomized controlled trial in 335 HD patients and randomly (1:1) assigned them to either (i) intradialytic exercise training plus usual care maintenance HD or (ii) usual care maintenance HD. The primary outcome of the study was the change in Kidney Disease Quality of Life Short Form (KDQOL-SF 1.3) Physical Component Score between baseline and 6 months. Additional secondary outcomes included changes in peak aerobic capacity, physical fitness, habitual physical activity levels and falls (International Physical Activity Questionnaire, Duke’s Activity Status Index and Tinetti Falls Efficacy Scale), QOL and symptom burden assessments (EQ5D), arterial stiffness (pulse wave velocity), anthropometric measures, resting blood pressure, clinical chemistry, safety and harms associated with the intervention, hospitalizations and cost-effectiveness. A nested qualitative study investigated the experience and acceptability of the intervention for both participants and members of the renal health care team. Results: At baseline assessment, 62.4% of the randomized cohort were male, the median age was 59.3 years and 50.4% were white. Prior cerebrovascular events and myocardial infarction were present in 8 and 12% of the cohort, respectively, 77.9% of patients had hypertension and 39.4% had diabetes. Baseline clinical characteristics and laboratory data for the randomized cohort were generally concordant with data from the UK Renal Registry. Conclusion: The results from this study will address a significant knowledge gap in the prescription of exercise interventions for patients receiving maintenance HD therapy and inform the development of intradialytic exercise programmes both nationally and internationally. Trial Registration: ISRCTN N83508514; registered on 17 December 2014.

• Item Type: Articles
• Additional Information: This study was funded by a grant from The National Institute for Health Research (grant number: NIHR-HTA 12/23/09).
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Kean, Ms Sharon and Ford, Professor Ian and Messow, Dr Martina and Thomson, Dr Peter
• Authors: Greenwood, S. A., Koufaki, P., Macdonald, J., Bhandari, S., Burton, J., Dasgupta, I., Farrington, K., Ford, I., Kalra, P. A., Kean, S., Kumwenda, M., Macdougall, I. C., Messow, C.-M., Mitra, S., Reid, C., Smith, A. C., Taal, M., Thomson, P. C., Wheeler, D. C., White, C., Yaqoob, M., and Mercer, T. H.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
• Journal Name: Clinical Kidney Journal
• Publisher: Oxford University Press
• ISSN: 2048-8505
• ISSN (Online): 2048-8513
• Published Online: 10 September 2020
• Copyright Holders: Copyright © 2020 The Authors
• First Published: First published in Clinical Kidney Journal 14(5):1345-1355
• Publisher Policy: Reproduced under a Creative Commons License