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The PrEscription of intraDialytic exercise to improve quAlity of Life (PEDAL) in patients with chronic kidney disease trial: Study design and baseline data for a multi-centre randomised controlled trial.

Version 2 2020-04-17, 15:05
Version 1 2020-04-17, 15:02
journal contribution
posted on 2020-04-17, 15:05 authored by Sharlene Greenwood, Pelagia Koufaki, Jamie Macdonald, Sunil Bhandari, James Burton, Indranil Dasgupta, Kenneth Farrington, Ian Ford, Philip Kalra, Sharon Kean, Mick Kumwenda, Iain Macdougall, Claudia Messow, Sandip Mitra, Reid Chante, Alice C Smith, Maarten Taal, Peter Thomson, David Wheeler, Claire White, Magdi Yaqoob, Thomas Mercer

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 PEDAL study aimed to evaluate the effectiveness of a 6-month intradialytic exercise programme on quality of life (QOL) and physical function, compared to usual care for patients on HD in the UK.

Methods: We conducted a prospective, pragmatic multicentre randomised controlled trial (RCT) 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 (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), quality of life and symptom burden assessments (EQ5D), arterial stiffness (pulse wave velocity), anthropometric measures, resting blood pressure, clinical chemistry, safety and harms associated with the intervention, hospitalisations, and cost-effectiveness. A nested qualitative study investigated the experience and acceptability of the intervention for both participants and members of the renal healthcare team.

Results: At baseline assessment, 62.4% of the randomised cohort were male, the median age was 59.3 years, and 50.4% were White. Prior cerebrovascular events and myocardial infarction (MI) were present in 8 and 12% of the cohort, respectively, 77.9% of patients had 3

hypertension and 39.4% had diabetes. Baseline clinical characteristic and laboratory data for the randomised 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 17th December 2014.

Funding

This study was funded by a grant from The National Institute for Health Research (grant number: NIHR-HTA 12/23/09.

History

Citation

Clinical Kidney Journal (2020) In Press

Version

  • AM (Accepted Manuscript)

Published in

Clinical Kidney Journal

Publisher

Oxford University Press (OUP)

issn

2048-8505

Acceptance date

2020-04-16

Copyright date

2020

Publisher version

TBA

Language

en

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