Browsing by Person "Dasgupta, Indranil"
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Item Body Composition and Intradialytic Exercise in Kidney Disease: A Combined Analysis of the PEDAL and CYCLE‐HD Randomised Controlled Trials(2025-03-03) Ng, Khai Ping; Macdonald, Jamie H.; Young, Robin; March, Daniel S.; Graham‐Brown, Matthew P. M.; Mercer, Tom; Greenwood, Sharlene; Burton, James O.; Dasgupta, IndranilBackground: Haemodialysis patients are at high risk of myopenic obesity, necessitating effective nutritional status monitoring and intervention strategies. This combined analysis of two clinical trials (PEDAL trial and CYCLE‐HD study) aimed to (i) determine the clinical utility of body mass index (BMI) in comparison to fat tissue index (FTI) and lean tissue index (LTI) and (ii) assess the effect of a 6‐month intradialytic exercise intervention compared to usual care on FTI and LTI. Methods: A priori secondary endpoints in both trials included BMI, FTI and LTI. BMI was classified by World Health Organisation definitions (underweight, healthy, overweight or obese). FTI and LTI were determined by Bioelectrical Impedance Spectroscopy and classified by previous research evidence (FTI of 4–15 kg/m2 and LTI of 15–20 kg/m2 being associated with best survival). For aim (i), BMI was compared to FTI and LTI by correlation and classification. For aim (ii), changes over 6 months in FTI and LTI were compared between exercise intervention and control groups. Results: Across both studies, 298 and 209 participants had bioelectrical impedance spectroscopy measurement at baseline and 6 months, respectively. Mean (SD) age: 58 (15) years; BMI: 28.2(6.3) kg/m2; male: 65%. At baseline, only 47 of 298 participants (16%) had an FTI and LTI associated with best survival. BMI correlated with FTI (r = 0.79; p < 0.0001). However, 34% of participants were misclassified by BMI (e.g., 9% of patients were classified as obese by BMI yet FTI revealed their body composition was healthy). BMI did not correlate with LTI (p = 0.15), and 86% of participants were misclassified by BMI (e.g., 73% of patients were classified as healthy, overweight or obese by BMI yet LTI revealed they were myopenic). There was no difference between exercise intervention and control groups in mean change (95% CI) over 6 months for LTI (−0.3 [−1.1 to 0.4] kg/m2; p = 0.4) or FTI (0.2 [−0.7 to 1.0] kg/m2; p = 0.7). Conclusions: Worryingly, only a minority (16%) of haemodialysis patients had both LTI and FTI within the range associated with best survival. Body composition misclassification using conventional BMI cut‐offs was common: despite having healthy, overweight or even obese BMI, the majority (73%) of patients had hidden myopenia according to LTI. Six months of intradialytic aerobic exercise did not improve body composition. This study identified that common measures of nutritional status in haemodialysis patients such as BMI are misleading and that interventions other than intradialytic cycling are urgently required to target myopenic obesity.Item 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, IndranilItem 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, TomBackground 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.Item 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, TomIntroduction: 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.Item 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, TomBackground 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.