TY - JOUR

T1 - Randomized Trial-PrEscription of intraDialytic exercise to improve quAlity of Life in Patients Receiving Hemodialysis

AU - Greenwood, Sharlene A.

AU - Koufaki, Pelagia

AU - Macdonald, Jamie

AU - Bhandari, Sunil

AU - Burton, James O.

AU - Dasgupta, Indranil

AU - Farrington, Kenneth

AU - Ford, Ian

AU - Kalra, Philip A

AU - Kean, Sharon

AU - Kumwenda, Mick

AU - Macdougall, Iain C

AU - Messow, Claudia-Martina

AU - Mitra, Sandip

AU - Reid, Chante

AU - Smith, Alice C

AU - Taal, Maarten W

AU - Thompson, Peter C.

AU - Wheeler, David C

AU - White, Claire

AU - Yaqoob, Magdi

AU - Mercer, Thomas

N1 - © 2021 International Society of Nephrology. Published by Elsevier Inc.

PY - 2021/8/1

Y1 - 2021/8/1

N2 - IntroductionWhether 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.MethodsIn 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.ResultsWe 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.ConclusionsA 6-month intradialytic aerobic exercise program was not clinically beneficial in improving HRQoL as delivered to this cohort of deconditioned patients on HD.

AB - IntroductionWhether 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.MethodsIn 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.ResultsWe 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.ConclusionsA 6-month intradialytic aerobic exercise program was not clinically beneficial in improving HRQoL as delivered to this cohort of deconditioned patients on HD.

KW - rehabilitation

KW - Physical activity

KW - Chronic Kidney Disease

KW - Physical Function

U2 - 10.1016/j.ekir.2021.05.034

DO - 10.1016/j.ekir.2021.05.034

M3 - Article

C2 - 34386665

VL - 6

SP - 2159

EP - 2170

JO - Kidney International Reports

JF - Kidney International Reports

SN - 2468-0249

IS - 8

ER -