Browsing by Person "Greenwood, Sharlene A."

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A randomized trial of intravenous iron supplementation and exercise on exercise capacity in iron-deficient non-anemic patients with chronic kidney disease
(Elsevier, 2023-05-09) Greenwood, Sharlene A.; Oliveira, Benjamin A.; Asgari, Elham; Ayis, Salma; Baker, Luke A.; Beckley-Hoelscher, Nicholas; Goubar, Aicha; Banerjee, Debasish; Bhandari, Sunil; Chilcot, Joseph; Burton, James O.; Kalra, Philip A.; Lightfoot, Courtney J.; Macdougall, Iain C.; McCafferty, Kieran; Mercer, Tom; Okonko, Darlington O.; Reid, Chante; Reid, Fiona; Smith, Alice C.; Swift, Pauline A.; Mangelis, Anastasios; Watson, Emma; Wheeler, David C.; Wilkinson, Thomas J.; Bramham, Kate
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.
Aerobic or Resistance Training and Pulse Wave Velocity in Kidney Transplant Recipients: A 12-Week Pilot Randomized Controlled Trial (the Exercise in Renal Transplant [ExeRT] Trial)
(2015-07-22) Greenwood, Sharlene A.; Koufaki, Pelagia; Mercer, Tom; Rush, Robert; O'Connor, Ellen; Tuffnell, Rachel; Lindup, Herolin; Haggis, Lynda; Dew, Tracy; Abdulnassir, Lyndsey; Nugent, Eilish; Goldsmith, David; Macdougall, Iain C.
Background: Cardiovascular disease remains the leading cause of death in kidney transplant recipients. This pilot study examined the potential effect of aerobic training or resistance training on vascular health and indexes of cardiovascular risk in kidney transplant recipients. Study Design: Single-blind, randomized, controlled, parallel trial. Setting & Participants: 60 participants (mean age, 54 years; 34 men) were randomly assigned to aerobic training (n = 20), resistance training (n = 20), or usual care (n = 20). Participants were included if they had a kidney transplant within 12 months prior to baseline assessment. Patients were excluded if they had unstable medical conditions or had recently started regular exercise. Intervention: Aerobic training and resistance training were delivered 3 days per week for a 12-week period. The usual-care group received standard care. Outcomes & Measurements: Pulse wave velocity, peak oxygen uptake (Vo 2peak), sit-to-stand 60, isometric quadriceps force, and inflammatory biomarkers were assessed at 0 and 12 weeks. Results: The anticipated 60 participants were recruited within 12 months. 46 participants completed the study (aerobic training, n=13; resistance training, n=13; and usual care, n=20), resulting in a 23% attrition rate. Analyses of covariance, adjusted for baseline values, age, and dialysis vintage pretransplantation, revealed significant mean differences between aerobic training and usual care in pulse wave velocity of-2.20.4 (95% CI,-3.1 to-1.3) m/s (P <0.001) and between resistance training and usual care of-2.60.4 (95% CI,-3.4 to-1.7) m/s (P <0.001) at 12 weeks. Secondary analyses indicated significant improvements in Vo 2peak in the aerobic training group and in Vo 2peak, sit-to-stand 60, and isometric muscle force in the resistance training group compared with usual care at 12 weeks. There were no reported adverse events, cardiovascular events, or hospitalizations as a result of the intervention. Limitations: Pilot study, small sample size, no measure of endothelial function. Conclusions: Both aerobic training and resistance training interventions appear to be feasible and clinically beneficial in this patient population. 2015 National Kidney Foundation, Inc.
Body Composition and Its Response to Intradialytic Exercise in Kidney Failure: A Combined Analysis of the PEDAL and CYCLE-HD Randomised Controlled Trials
(Ovid Technologies (Wolters Kluwer Health), 2023-11) Ng, Khai Ping; Macdonald, Jamie H.; Young, Robin; March, Daniel S.; Graham-Brown, Matthew; Mercer, Tom; Greenwood, Sharlene A.; Burton, James; Dasgupta, Indranil
Effect of Exercise Training on Estimated GFR, Vascular Health, and Cardiorespiratory Fitness in Patients With CKD: A Pilot Randomized Controlled Trial
(2014-09-15) Greenwood, Sharlene A.; Koufaki, Pelagia; Mercer, Tom; MacLaughlin, Helen L.; Rush, Robert; Lindup, Herolin; O'Connor, Ellen; Jones, Christopher; Hendry, Bruce M.; Macdougall, Iain C.; Cairns, Hugh S.
Background: Exercise capacity, which is predictive of all-cause mortality and cardiovascular disease risk, is reduced significantly in patients with non-dialysis-dependent chronic kidney disease. This pilot study examined the effect of moderate-intensity exercise training on kidney function and indexes of cardiovascular risk in patients with progressive chronic kidney disease stages 3 to4. Study Design: Single-blind, randomized, controlled, parallel trial. Setting & Participants: 20 patients (aged 18-80 years; 17 men) randomly assigned to rehabilitation (n=10) or usual care (n=10). Participants were included if they were 18 years or older and had evidence of rate of decline in creatinine-based estimated glomerular filtration rate (eGFRcr)≥2.9mL/min/1.73m2 per year for 12 months preintervention. Patients were excluded if they had unstable medical conditions or had recently started regular exercise. Intervention: The rehabilitation group received resistance and aerobic training (3 days per week) for a 12-month period. The usual care group received standard care. Outcomes: Kidney function assessed by comparing mean rate of change in eGFRcr (mL/min/1.73m2 per year) from a 12-month preintervention period against the 12-month intervention period. Pulse wave velocity (PWV), peak oxygen uptake (Vo 2peak), and waist circumference assessed at 0, 6, and 12 months. Measurements: eGFR assessed using creatinine, cystatin C (eGFRcys), and a combination of both values (eGFRcr-cys). Results: 18 participants (rehabilitation, 8; usual care, 10) completed the study. A significant mean difference in rate of change in eGFRcr (+7.8±3.0 [95% CI, 1.1-13.5] mL/min/1.73m2 per year; P =0.02) was observed between the rehabilitation and usual care groups, with the rehabilitation group demonstrating a slower decline. No significant between-group mean differences existed in absolute eGFRcr, eGFRcr-cys, or eGFRcys at 12 months of study intervention. Significant between-group mean differences existed in PWV (-2.30 [95% CI,-3.02 to-1.59] m/s), waist circumference (-7.1±12.8 [95% CI,-12.4 to-3.2] cm), and Vo 2peak (5.7 [95% CI, 1.34-10.10] mL/kg/min). Change in eGFRcr was correlated inversely with PWV (r =-0.5; P =0.04) at 12 months. Limitations: Small sample size, inconsistency between primary and secondary measures of kidney function. Conclusions: The effect of a 1-year exercise intervention on progression of kidney disease is inconclusive. A larger study with longer follow-up may be necessary.
Exercise programme to improve quality of life for patients with end-stage kidney disease receiving haemodialysis: The PEDAL RCT
(National Institute for Health Research, 2021-06) Greenwood, Sharlene A.; Koufaki, Pelagia; Macdonald, Jamie; Bulley, Catherine; Bhandari, Sunil; Burton, James; Dasgupta, Indranil; Farrington, Kenneth; Ford, Ian; Kalra, Philip A.; Kumwenda, Mick; Macdougall, Iain C.; Messow, Claudia-Martina; Mitra, Sandip; Reid, Chante; Smith, Alice C.; Taal, Maarten W.; Thomson, Peter C.; Wheeler, David C.; White, Claire; Yaqoob, Magdi; Mercer, Tom
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, n = 127; control, n = 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; p = 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 (n = 69) and control (n = 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 Health Technology Assessment; Vol. 25, No. 40. See the NIHR Journals Library website for further project information.
Exercise Therapy in Individuals With Chronic Kidney Disease: A Systematic Review and Synthesis of the Research Evidence
(Springer, 2013-10) Koufaki, Pelagia; Greenwood, Sharlene A.; Macdougall, I. C.; Mercer, Tom
Chronic kidney disease (CKD) is becoming a serious health problem throughout the world and is one of the most potent known risk factors for cardiovascular disease (CVD) which is considered the leading cause of morbidity and mortality in this cohort of patients. Additional independent risk factors for poor health outcomes among many include diabetes, physical inactivity and physical dysfunction. Physical inactivity partly contributes to the accelerated deterioration of physical function in people in all stages of CKD, to levels that significantly impact on clinically and patient important outcomes such as morbidity, employment, quality of life (QoL) and ultimately survival. Ongoing research aims to determine the effectiveness and impact of exercise rehabilitation on reducing/ managing the risk of CVD, alleviating physical function limitations, preventing disability and enhancing QoL. Current research also aims to elucidate the mechanisms via which exercise therapy may contribute to clinically relevant benefits. An evaluative overview of the available evidence from experimental interventions to modify PA levels, highlights the huge variability in exercise training and assessment protocols utilised and inconsistency in reporting procedures that hampers, systematic synthesis of the evidence. Nonetheless, the general conclusion that can be deciphered is that a mixed cardiovascular and resistance training programme that lasts at least 4-6 months, results in significant improvements in cardiorespiratory fitness. However, this level of improvement, does not consistently and meaningfully translates into enhanced CV risk profile or renal function, or QoL, even in the presence of improved physical function as a result of increased PA levels. The relatively short duration of interventions as well as the extremely small sample sizes, combined with the inherent large variability in individual responses and progression, may be partially responsible for the lack of a systematic and consistent effect. Moreover, the dose of exercise may have not been sufficient to produce larger effects in relatively short periods of time. Thus, although the research evidence base needs more work, that should incorporate more accurate and systematic approaches in the prescription and delivery of exercise dosage, the association between exercise and some enhanced outcomes in the CKD population is sufficiently strong to recognise the potential importance of this area of renal care and further invest in it.
Feasibility of randomized controlled trials and long-term implementation of interventions: Insights from a qualitative process evaluation of the PEDAL trial
(Frontiers Media S.A., 2023-02-01) Bulley, Catherine; Koufaki, Pelagia; Macdonald, Jamie Hugo; Macdougall, Iain C.; Mercer, Tom; Scullion, Jane; Greenwood, Sharlene A.
Introduction: A multi-site randomized controlled trial was carried out between 2015 and 2019 to evaluate the impacts on quality of life of an intradialytic exercise programme for people living with chronic kidney disease. This included a qualitative process evaluation which gave valuable insights in relation to feasibility of the trial and of the intervention in the long-term. These can inform future clinical Trial design and evaluation studies. Methods: A constructivist phenomenological approach underpinned face-to-face, semi-structured interviews. Purposive recruitment ensured inclusion of participants in different arms of the PEDAL Trial, providers with different roles and trial team members from seven Renal Units in five study regions. Following ethical review, those willing took part in one interview in the Renal Unit. Audio-recorded interviews were transcribed (intelligent verbatim) and inductively thematically analyzed. Results: Participants (n = 65) (Intervention arm: 26% completed; 13% who did not; Usual care arm: 13%; 46% women; 54% men; mean age 60 year) and providers (n = 39) were interviewed (23% PEDAL Trial team members). Three themes emerged: (1) Implementing the Intervention; (2) Implementing the trial; and (3) Engagement of the clinical team. Explanatory theory named “the Ideal Scenario” was developed, illustrating complex interactions between different aspects of intervention and trial implementation with the clinical context. This describes characteristics likely to optimize trial feasibility and intervention sustainability in the long-term. Key aspects of this relate to careful integration of the trial within the clinical context to optimize promotion of the trial in the short-term and engagement and ownership in the long-term. Strong leadership in both the clinical and trial teams is crucial to ensure a proactive and empowering culture. Conclusion: Novel explanatory theory is proposed with relevance for Implementation Science. The “Ideal Scenario” is provided to guide trialists in pre-emptive and ongoing risk analysis relating to trial feasibility and long-term intervention implementation. Alternative study designs should be explored to minimize the research-to-practice gap and optimize the likelihood of informative findings and long-term implementation. These might include Realist Randomized Controlled Trials and Hybrid Effectiveness-Implementation studies.
Intra-dialytic exercise training: A pragmatic approach
(Wiley-Blackwell, 2014-09) Greenwood, Sharlene A.; Naish, Patrick; Clark, Rachel; O'Connor, Ellen; Pursey, Victoria A.; Macdougall, Iain C.; Mercer, Tom; Koufaki, Pelagia
This continuing education paper outlines the skills and knowledge required to plan, implement and evaluate a pragmatic approach to intra-dialytic exercise training. Aim: The aim of this continuing education article is to enable the nephrology multi-disciplinary team (MDT) to plan, implement and evaluate the provision of intra-dialytic exercise training for patients receiving haemodialysis therapy. LEARNING OUTCOMES: After reading this article the reader should be able to: Appreciate the level of evidence base for the clinical effectiveness of renal exercise rehabilitation and locate credible sources of research and educational information Understand and consider the need for appropriate evaluation and assessment outcomes as part of a renal rehabilitation plan Understand the components of exercise programming and prescription as part of an integrated renal rehabilitation plan Develop a sustainable longer term exercise and physical activity plan. 2014 The Authors.
Kidney Beam - a cost-effective digital intervention to improve mental health.
(Elsevier, 2024-09-02) Greenwood, Sharlene A.; Briggs, Juliet; Walklin, Christy; Mangahis, Emmanuel; Young, Hannah ML.; Castle, Ellen M.; Billany, Roseanne E.; Asgari, Elham; Bhandari, Sunil; Bishop, Nicolette; Bramham, Kate; Burton, James O.; Campbell, Jackie; Chilcot, Joseph; Cooper, Nicola; Deelchand, Vashist; Graham-Brown, Matthew PM.; Haggis, Lynda; Hamilton, Alexander; Jesky, Mark; Kalra, Philip A.; Koufaki, Pelagia; McCafferty, Kieran; Nixon, Andrew C.; Noble, Helen; Saynor, Zoe L.; Taal, Maarten W.; Tollitt, James; Wheeler, David C.; Wilkinson, Thomas J.; Worboys, Hannah; Macdonald, Jamie
Background There is inequity in provision of physical rehabilitation services for people living with chronic kidney disease (CKD). The Kidney BEAM trial evaluated the clinical value and cost effectiveness of a physical activity digital health intervention in CKD. Methods In a single-blind, 11 centre, randomised controlled trial, 340 adult participants with CKD were randomly assigned to either the Kidney BEAM physical activity digital health intervention or a waitlist control. This study assesses the difference in the Kidney Disease Quality of Life Short Form 1.3 Mental Component Summary (KDQoL-SF1.3 MCS) between intervention and control groups at 6 months, and cost-effectiveness of the intervention. Results At 6 months there was a significant difference in mean adjusted change in KDQoL MCS score between Kidney BEAM and waitlist control (intention-to-treat adjusted mean: 5.9 {95% confidence interval: 4.4 to 7.5} arbitrary units, p<0.0001), and a 93% and 98% chance of the intervention being cost-effective at a willingness to pay threshold of £20,000 and £30,000 per quality-adjusted life year gained. Conclusion The Kidney BEAM physical activity digital health intervention is a clinically valuable and cost-effective means to improve mental health related quality of life in people with CKD (trial registration no. NCT04872933).
Long-term pulse wave velocity outcomes with aerobic and resistance training in kidney transplant recipients - A pilot randomised controlled trial
(Public Library of Science, 2017-02-03) O'Connor, Ellen M.; Koufaki, Pelagia; Mercer, Tom; Lindup, Herolin; Nugent, Eilish; Goldsmith, David; Macdougall, Iain C.; Greenwood, Sharlene A.
Background This pilot study examined long-term pulse wave velocity (PWV) and peak oxygen uptake (VO2peak) outcomes following a 12-week moderate-intensity aerobic or resistance training programme in kidney transplant recipients. Method Single-blind, bi-centre randomised controlled parallel trial. 42 out of 60 participants completed a 9-month follow-up assessment (Aerobic training = 12, Resistance training = 10 and usual care = 20). Participants completed 12 weeks of twice-weekly supervised aerobic or resistance training. Following the 12-week exercise intervention, participants were transitioned to self-managed community exercise activity using motivational interviewing techniques. Usual care participants received usual encouragement for physical activity during routine clinical appointments in the transplant clinic. PWV, VO2peak, blood pressure and body weight were assessed at 12 weeks and 12 months, and compared to baseline. Results ANCOVA analysis, covarying for baseline values, age, and length of time on dialysis pretransplantation, revealed a significant mean between-group difference in PWV of -1.30 m/ sec (95%CI -2.44 to -0.17, p = 0.03) between resistance training and usual care groups. When comparing the aerobic training and usual care groups at 9-month follow-up, there was a mean difference of -1.05 m/sec (95%CI -2.11 to 0.017, p = 0.05). A significant mean between-group difference in relative VO2peak values of 2.2 ml/kg/min (95% CI 0.37 to 4.03, p = 0.02) when comparing aerobic training with usual care was revealed. There was no significant between group differences in body weight or blood pressure. There were no significant adverse effects associated with the interventions. Conclusions Significant between-group differences in 9-month follow-up PWV existed when comparing resistance exercise intervention with usual care. A long-term between-group difference in VO2peak was only evident when comparing aerobic intervention with usual care. This pilot study, with a small sample size, did not aim to elucidate mechanistic mediators related to the exercise interventions. It is however suggested that a motivational interviewing approach, combined with appropriate transition to community training programmes, could maintain the improvements gained from the 12-week exercise interventions and further research in this area is therefore warranted. 2017 O'Connor et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Randomized Trial—PrEscription of intraDialytic exercise to improve quAlity of Life in Patients Receiving Hemodialysis
(International Society of Nephrology, 2021-05-30) Greenwood, Sharlene A.; Koufaki, Pelagia; Macdonald, Jamie; Bhandari, Sunil; Burton, James; Dasgupta, Indranil; Farrington, Kenneth; Ford, Ian; Kalra, Philip A.; Kean, Sharon; Kumwenda, Mick; Macdougall, Iain C.; Messow, Claudia-Martina; Mitra, Sandip; Reid, Chante; Smith, Alice C.; Taal, Maarten W.; Thomson, Peter C.; Wheeler, David C.; White, Claire; Yaqoob, Magdi; Mercer, Tom
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 costeffectiveness of a 6-month intradialytic exercise program.
The development and internal pilot trial of a digital physical activity and emotional well-being intervention (Kidney BEAM) for people with chronic kidney disease
(Nature Publishing Group UK, 2024-01-06) Young, Hannah M.; Castle, Ellen M.; Briggs, Juliet; Walklin, Christy; Billany, Roseanne E.; Asgari, Elham; Bhandari, Sunil; Bishop, Nicolette; Bramham, Kate; Burton, James O.; Campbell, Jackie; Chilcot, Joseph; Cooper, Nicola; Deelchand, Vashist; Graham-Brown, Matthew P. M.; Haggis, Lynda; Hamilton, Alexander; Jesky, Mark; Kalra, Philip A.; Koufaki, Pelagia; Macdonald, Jamie; McCafferty, Kieran; Nixon, Andrew C.; Noble, Helen; Saynor, Zoe L.; Taal, Maarten W.; Tollitt, James; Wheeler, David C.; Wilkinson, Thomas J.; Greenwood, Sharlene A.
This trial assessed the feasibility and acceptability of Kidney BEAM, a physical activity and emotional well-being self-management digital health intervention (DHI) for people with chronic kidney disease (CKD), which offers live and on-demand physical activity sessions, educational blogs and videos, and peer support. In this mixed-methods, multicentre randomised waitlist-controlled internal pilot, adults with established CKD were recruited from five NHS hospitals and randomised 1:1 to Kidney BEAM or waitlist control. Feasibility outcomes were based upon a priori progression criteria. Acceptability was primarily explored via individual semi-structured interviews (n = 15). Of 763 individuals screened, n = 519 (68%, 95% CI 65 to 71%) were eligible. Of those eligible, n = 303 (58%, 95% CI 54–63%) did not respond to an invitation to participate by the end of the pilot period. Of the 216 responders, 50 (23%, 95% CI 18–29%) consented. Of the 42 randomised, n = 22 (10 (45%) male; 49 ± 16 years; 14 (64%) White British) were allocated to Kidney BEAM and n = 20 (12 (55%) male; 56 ± 11 years; 15 (68%) White British) to the waitlist control group. Overall, n = 15 (30%, 95% CI 18–45%) withdrew during the pilot phase. Participants completed a median of 14 (IQR 5–21) sessions. At baseline, 90–100% of outcome data (patient reported outcome measures and a remotely conducted physical function test) were completed and 62–83% completed at 12 weeks follow-up. Interview data revealed that remote trial procedures were acceptable. Participants’ reported that Kidney BEAM increased their opportunity and motivation to be physically active, however, lack of time remained an ongoing barrier to engagement with the DHI. An randomised controlled trial of Kidney BEAM is feasible and acceptable, with adaptations to increase recruitment, retention and engagement. Trial registration NCT04872933. Date of first registration 05/05/2021.
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
(Oxford University Press, 2020-09-10) Greenwood, Sharlene A.; Koufaki, Pelagia; Macdonald, Jamie; Bhandari, Sunil; Burton, James; Dasgupta, Indranil; Farrington, Kenneth; Ford, Ian; Kalra, Philip A.; Kean, Sharon; Kumwenda, Mick; Macdougall, Iain C.; Messow, Claudia-Martina; Mitra, Sandip; Reid, Chante; Smith, Alice C.; Taal, Maarten W.; Thomson, Peter C.; Wheeler, David C.; White, Claire; Yaqoob, Magdi; Mercer, Tom
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.