University of Hertfordshire

  • Sharlene A. Greenwood
  • Pelagia Koufaki
  • Jamie H. Macdonald
  • Sunil Bhandari
  • James O. Burton
  • Indranil Dasgupta
  • Ian Ford
  • Philip A. Kalra
  • Sharon Kean
  • Mick Kumwenda
  • Iain C. Macdougall
  • Claudia Martina Messow
  • Sandip Mitra
  • Chante Reid
  • Alice C. Smith
  • Maarten W. Taal
  • Peter C. Thomson
  • David C. Wheeler
  • Claire White
  • Magdi Yaqoob
  • Thomas H. Mercer
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Original languageEnglish
JournalKidney International Reports
DOIs
Publication statusAccepted/In press - 25 May 2021
Externally publishedYes

Abstract

Introduction: Whether clinically implementable exercise interventions in people receiving hemodialysis (HD) therapy improve health-related quality of life (HRQoL) remains unknown. The PrEscription of intraDialytic exercise to improve quAlity of Life (PEDAL) study evaluated the clinical benefit and cost-effectiveness of a 6-month intradialytic exercise program. Methods: In a multicenter, single-blinded, randomized, controlled trial, people receiving HD were randomly assigned to (i) intradialytic exercise training (exercise intervention group [EX]) and (ii) usual care (control group [CON]). Primary outcome was change in Kidney Disease Quality of Life Short-Form Physical Component Summary (KDQOL-SF 1.3 PCS) from baseline to 6 months. Cost-effectiveness was determined using health economic analysis; physiological impairment was evaluated by peak oxygen uptake; and harms were recorded. Results: We randomized 379 participants; 335 and 243 patients (EX n = 127; CON n = 116) completed baseline and 6-month assessments, respectively. Mean difference in change PCS from baseline to 6 months between EX and CON was 2.4 (95% confidence interval [CI]: −0.1 to 4.8) arbitrary units (P = 0.055); no improvements were observed in peak oxygen uptake or secondary outcome measures. Participants in the intervention group had poor compliance (47%) and poor adherence (18%) to the exercise prescription. Cost of delivering intervention ranged from US$598 to US$1092 per participant per year. The number of participants with harms was similar between EX (n = 69) and CON (n = 56). A primary limitation was the lack of an attention CON. Many patients also withdrew from the study or were too unwell to complete all physiological outcome assessments. Conclusions: A 6-month intradialytic aerobic exercise program was not clinically beneficial in improving HRQoL as delivered to this cohort of deconditioned patients on HD.

Notes

Funding Information: We are grateful to the research assistants, physiotherapy assistants, and research nurses who facilitated completion of this study. This study is funded by a grant from the National Institute for Health Research (grant number: NIHR-HTA 12/23/09). The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the National Institute for Health Research, or the Department of Health. The funders had no role in the design, collection, analysis, and interpretation of the data or writing of this protocol. SM is supported by NIHR infrasructure in D4D MIC Sheffield, UK. SAG, PK, JHM, ICM, IF, AS, and TM conceived and designed the study; IF and CMM analyzed the data; SAG, JHM, and PK interpreted and contextualized the data and drafted the paper; SAG, JHM, PK, DW, SB, KF, MT, PAK, MK, JB, ICM, IF, CMM, SK, CR, IDG, CR, MY, PT, SM, TM, and AS revised the paper; all authors approved the final manuscript. Funding Information: We are grateful to the research assistants, physiotherapy assistants, and research nurses who facilitated completion of this study. This study is funded by a grant from the National Institute for Health Research (grant number: NIHR-HTA 12/23/09). The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the National Institute for Health Research, or the Department of Health. The funders had no role in the design, collection, analysis, and interpretation of the data or writing of this protocol. SM is supported by NIHR infrasructure in D4D MIC Sheffield, UK. Publisher Copyright: © 2021 International Society of Nephrology Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

ID: 25651147