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

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  = 127; CON  = 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 ( = 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 ( = 69) and CON ( = 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

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

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 3hypertension 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.</p

Voices from the field: How did you come to engage in students-as-partners work?

The language of students as partners was cemented into higher education (HE) practice and scholarship 10 years ago. While it had been circulating in higher education policy, practices, and publications before that, two key 2014 publications on engaging students as partners, or SaP, inspired a myriad of practices and publications brought together by the relational, values-based ethos of partnership (Cook-Sather et al., 2014; Healey et al., 2014). A seductively simple idea— that students can collaborate with staff as partners on matters of teaching and learning—landed at the right time. The higher education sector was increasingly fixated on student involvement and engagement, particularly on how university changes students (Klemenčič, 2024). SaP offered a related but direction-shifting proposition: what if students could shape higher education

Intravenous Iron Dosing and Infection Risk in Patients on Hemodialysis : A Prespecified Secondary Analysis of the PIVOTAL Trial

Funding Information: Dr. Anker reports grants and personal fees from Vifor Int, personal fees from Bayer, personal fees from Boehringer Ingelheim, personal fees from Novartis, personal fees from Servier, grants and personal fees from Abbott Vascular, personal fees from Impulse Dynamics, and personal fees from SJM outside the submitted work. Dr. Bhandari reports personal fees from Phar-macosmos and personal fees from Vifor Pharma during the conduct of the study. Dr. Ford reports grants from Kidney Research UK during the conduct of the study. Dr. Kalra reports grants and personal fees from Vifor during the conduct of the study as well as grants and personal fees from Vifor, personal fees from Pharmacosmos, grants and personal fees from Astellas, personal fees from Bayer, personal fees from MundiPharma, personal fees from Napp, personal fees from AstraZeneca, grants from BergenBio, personal fees from Boehringer Ingelheim, and personal fees from Novonordisk outside the submitted work. Dr. Mark reports personal fees and nonfinancial support from Vifor, personal fees from Astrazeneca, grants from Boehringer Ingelheim, personal fees and nonfinancial support from Pharmacosmos, personal fees from Jans-sen, personal fees from Novartis, personal fees from Pfizer, personal fees from Bristol Myers Squibb, and personal fees and nonfinancial support from Napp outside the submitted work. Dr. Macdougall reports grants and personal fees from Vifor Pharma outside the submitted work. Dr. McMurray reports nonfinancial support and other from AstraZeneca during the conduct of the study as well as other from Bayer, nonfinancial support and other from Cardiorentis, nonfinancial support and other from Amgen, nonfinancial support and other from Oxford University/Bayer, nonfinancial support and other from Thera-cos, nonfinancial support and other from Abbvie, other from DalCor, other from Pfizer, other from Merck, nonfinancial support and other from Novartis, nonfinancial support and other from Glaxo Smith Kline, other from Bristol Myers Squibb, nonfinancial support and other from Vifor-Fresenius, nonfinancial support and other from Kidney Research UK, and nonfinancial support and other from Novartis outside the submitted work. Dr. Robertson reports grants from University of Glasgow during the conduct of the study. Dr. Wheeler reports grants and personal fees from Vifor Fresenius during the conduct of the study as well as personal fees from Amgen, personal fees from AstraZeneca, personal fees from Bayer, personal fees from Boehringer Inge-hiem, personal fees from GlaxoSmithKline, personal fees from Janssen, personal fees from Napp, personal fees from Mundipharma, and personal fees from Reata outside the submitted work. All remaining authors have nothing to disclose. Funding Information: The Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial was funded by Kidney Research UK, which was supported by an unrestricted grant from Vifor Fresenius Medical Care Renal Pharma Ltd. Publisher Copyright: Copyright © 2020 by the American Society of Nephrology.BACKGROUND: Experimental and observational studies have raised concerns that giving intravenous (IV) iron to patients, such as individuals receiving maintenance hemodialysis, might increase the risk of infections. The Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial randomized 2141 patients undergoing maintenance hemodialysis for ESKD to a high-dose or a low-dose IV iron regimen, with a primary composite outcome of all-cause death, heart attack, stroke, or hospitalization for heart failure. Comparison of infection rates between the two groups was a prespecified secondary analysis. METHODS: Secondary end points included any infection, hospitalization for infection, and death from infection; we calculated cumulative event rates for these end points. We also interrogated the interaction between iron dose and vascular access (fistula versus catheter). RESULTS: We found no significant difference between the high-dose IV iron group compared with the lose-dose group in event rates for all infections (46.5% versus 45.5%, respectively, which represented incidences of 63.3 versus 69.4 per 100 patient years, respectively); rates of hospitalization for infection (29.6% versus 29.3%, respectively) also did not differ. We did find a significant association between risk of a first cardiovascular event and any infection in the previous 30 days. Compared with patients undergoing dialysis with an arteriovenous fistula, those doing so via a catheter had a higher incidence of having any infection, hospitalization for infection, or fatal infection, but IV iron dosing had no effect on these outcomes. CONCLUSIONS: The high-dose and low-dose IV iron groups exhibited identical infection rates. Risk of a first cardiovascular event strongly associated with a recent infection.Peer reviewe

A randomized trial of intravenous iron supplementation and exercise on exercise capacity in iron-deficient non-anemic patients with chronic kidney disease

From Elsevier via Jisc Publications RouterHistory: accepted 2023-05-01, issued 2023-05-09AM replaced with VoR 2023-08-21.Introduction Patients with chronic kidney disease (CKD) are often iron deficient, even when not anemic. This trial evaluated whether iron supplementation enhances exercise capacity. Methods Prospective, multicenter double-blind randomized controlled trial of non-dialysis patients with CKD and iron deficiency but without anemia (Hemoglobin (Hb)>110 g/l). Patients assigned (1:1): intravenous (IV) iron therapy, or placebo. An 8-week exercise programme commenced at week 4. Primary outcome was mean between-group difference in six-minute walk test (6MWT) at 4 weeks. Secondary outcomes included: 6MWT at 12 weeks, Transferrin Saturation (TSAT), serum ferritin (SF), hemoglobin (Hb), renal function, muscle strength, functional capacity, quality of life and adverse events at baseline, 4, 12 weeks. Mean between-group differences were analysed using ANCOVA models. Results Among 75 randomized patients, mean (SD) age for iron therapy (n=37) vs placebo (n=38) was 54(16) vs. 61(12) yrs; eGFR [34(12) vs. 35(11)ml/min/1.73m2], TSAT [23(12) vs. 21(6)]%; SF [57(64) vs. 62(33)]μg/L; Hb [122.4 (9.2) vs. 127 (13.2)g/L]; 6MWT [384 (195) vs. 469 (142)metres] at baseline, respectively. No significant mean between-group difference was observed in 6MWT distance at 4 weeks. There were significant increases in SF and TSAT at 4 and 12 weeks (p<0.02), and Hb at 12 weeks (p=0.009). There were no between-group differences in other secondary outcomes and no adverse events attributable to iron therapy. Conclusion This trial didn’t demonstrate beneficial effects of IV iron therapy on exercise capacity at 4 weeks. A larger study is needed to confirm if IV iron is beneficial in non-dialysis patients with CKD who are iron-deficient. Trial Registration EudraCT: 2018-000144-25 Registered 28/01/2019.pubpu

Exercise programme to improve quality of life for patients with end-stage kidney disease receiving haemodialysis: the PEDAL RCT.

BACKGROUND Whether or not clinically implementable exercise interventions in haemodialysis patients improve quality of life remains unknown. OBJECTIVES 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. DESIGN 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. SETTING The setting was five dialysis units across the UK from 2015 to 2019. PARTICIPANTS The participants were adult patients with end-stage kidney disease who had been receiving haemodialysis therapy for > 1 year. INTERVENTIONS Participants were randomised to receive usual-care maintenance haemodialysis or usual-care maintenance haemodialysis plus intradialytic exercise training. MAIN OUTCOME MEASURES 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. RESULTS We randomised 379 participants; 335 patients completed baseline assessments and 243 patients (intervention,  = 127; control,  = 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;  = 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 ( = 69) and control ( = 56) groups. LIMITATIONS Participants could not be blinded to the intervention; however, outcome assessors were blinded to group allocation. CONCLUSIONS 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. FUTURE WORK 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. TRIAL REGISTRATION Current Controlled Trials ISRCTN83508514. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 40. See the NIHR Journals Library website for further project information

A Randomized Trial of Intravenous Iron Supplementation and Exercise on Exercise Capacity in Iron-Deficient Nonanemic Patients With CKD

Introduction Patients with chronic kidney disease (CKD) are often iron deficient, even when not anemic. This trial evaluated whether iron supplementation enhances exercise capacity of nonanemic patients with CKD who have iron-deficiency. Methods Prospective, multicenter double-blind randomized controlled trial of nondialysis patients with CKD and iron-deficiency but without anemia (Hemoglobin [Hb] >110 g/l). Patients were assigned 1:1 to intravenous (IV) iron therapy, or placebo. An 8-week exercise program commenced at week 4. The primary outcome was the mean between-group difference in 6-minute walk test (6MWT) at 4 weeks. Secondary outcomes included 6MWT at 12 weeks, transferrin saturation (TSAT), serum ferritin (SF), Hb, renal function, muscle strength, functional capacity, quality of life, and adverse events at baseline, 4 weeks, and at 12 weeks. Mean between-group differences were analyzed using analysis of covariance models. Results Among 75 randomized patients, mean (SD) age for iron therapy (n = 37) versus placebo (n = 38) was 54 (16) versus 61 (12) years; estimated glomerular filtration rate (eGFR) (34 [12] vs. 35 [11] ml/min per 1.73 m2], TSAT (23 [12] vs. 21 [6])%; SF (57 [64] vs. 62 [33]) μg/l; Hb (122.4 [9.2] vs. 127 [13.2] g/l); 6MWT (384 [95] vs. 469 [142] meters) at baseline, respectively. No significant mean between-group difference was observed in 6MWT distance at 4 weeks. There were significant increases in SF and TSAT at 4 and 12 weeks (P Conclusion This trial did not demonstrate beneficial effects of IV iron therapy on exercise capacity at 4 weeks. A larger study is needed to confirm if IV iron is beneficial in nondialysis patients with CKD who are iron-deficient.</p