Browsing by Person "Bhandari, Sunil"

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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.
Evaluating the effect of a digital health intervention to enhance physical activity in people with chronic kidney disease (Kidney BEAM): a multicentre, randomised controlled trial in the UK
(Elsevier, 2023-11-14) Greenwood, Sharlene A; Young, Hannah M L; Briggs, Juliet; Castle, Ellen M; Walklin, Christy; Haggis, Lynda; Balkin, Caitlin; Asgari, Elham; Bhandari, Sunil; Burton, James O; Billany, Roseanne E; Bishop, Nicolette C; Bramham, Kate; Campbell, Jackie; Chilcot, Joseph; Cooper, Nicola J; Deelchand, Vashist; Graham-Brown, Matthew M P; Hamilton, Alexander; Jesky, Mark; Kalra, Philip A; Koufaki, Pelagia; McCafferty, Kieran; Nixon, Andrew C; Noble, Helen; Saynor, Zoe; Taal, Maarten W; Tollit, James; Wheeler, David C; Wilkinson, Thomas J; Worboys, Hannah; Macdonald, Jamie H
Background Remote digital health interventions to enhance physical activity provide a potential solution to improve the sedentary behaviour, physical inactivity, and poor health-related quality of life that are typical of chronic conditions, particularly for people with chronic kidney disease. However, there is a need for high-quality evidence to support implementation in clinical practice. The Kidney BEAM trial evaluated the clinical effect of a 12-week physical activity digital health intervention on health-related quality of life. Methods In a single-blind, randomised controlled trial conducted at 11 centres in the UK, adult participants (aged ≥18 years) with chronic kidney disease were recruited and randomly assigned (1:1) to the Kidney BEAM physical activity digital health intervention or a waiting list control group. Randomisation was performed with a web-based system, in randomly permuted blocks of six. Outcome assessors were masked to treatment allocation. The primary outcome was the difference in the Kidney Disease Quality of Life Short Form version 1.3 Mental Component Summary (KDQoL-SF1.3 MCS) between baseline and 12 weeks. The trial was powered to detect a clinically meaningful difference of 3 arbitrary units (AU) in KDQoL-SF1.3 MCS. Outcomes were analysed by an intention-to-treat approach using an analysis of covariance model, with baseline measures and age as covariates. The trial was registered with ClinicalTrials.gov, NCT04872933. Findings Between May 6, 2021, and Oct 30, 2022, 1102 individuals were assessed for eligibility, of whom 340 participants were enrolled and randomly assigned to the Kidney BEAM intervention group (n=173) or the waiting list control group (n=167). 268 participants completed the trial (112 in the Kidney BEAM group and 156 in the waiting list control group). All 340 randomly assigned participants were included in the intention-to treat population. At 12 weeks, there was a significant improvement in KDQoL-SF.13 MCS score in the Kidney BEAM group (from mean 44·6 AU [SD 10·8] at baseline to 47·0 AU [10·6] at 12 weeks) compared with the waiting list control group (from 46·1 AU [10·5] to 45·0 AU [10·1]; between-group difference of 3·1 AU [95% CI 1·8–4·4]; p<0·0001). Interpretation The Kidney BEAM physical activity platform is an efficacious digital health intervention to improve mental health-related quality of life in patients with chronic kidney disease. These findings could facilitate the incorporation of remote digital health interventions into clinical practice and offer a potential intervention worthy of investigation in other chronic conditions.
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.
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).
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 effect of intravenous iron supplementation on exercise capacity in iron-deficient but not anaemic patients with chronic kidney disease: study design and baseline data for a multicentre prospective double-blind randomised controlled trial.
(2022-07-27) Greenwood, Sharlene A; Beckley-Hoelscher, Nicholas; Asgari, Elham; Ayis, Salma; Baker, Luke A; Banerjee, Debasish; Bhandari, Sunil; Bramham, Kate; Chilcot, Joseph; Burton, James; Kalra, Philip A; Lightfoot, Courtney J; McCafferty, Kieran; Mercer, Tom; Okonko, Darlington O; Oliveira, Benjamin; Reid, Chante; Smith, Alice C; Swift, Pauline A; Mangelis, Anastasios; Watson, Emma; Wheeler, David C; Wilkinson, Thomas J; Reid, Fiona; Macdougall, Iain C
Background
Many people living with chronic kidney disease (CKD) are iron deficient, even though they may not be anaemic. The Iron and Muscle study aims to evaluate whether iron supplementation reduces symptoms of fatigue, improves muscle metabolism, and leads to enhanced exercise capacity and physical function. We report here the trial design and baseline characteristics.
Methods
This is a prospective, double-blind multicentre randomised controlled trial (RCT) including 75 non-dialysis stage 3-4 CKD patients with iron deficiency but without anaemia. Patients were randomly (1:1) assigned to either: i) intravenous iron therapy, or ii) placebo, with concurrent recruitment of eight CKD non-iron deficient participants and six healthy volunteers. The primary outcome of the study is the six-minute walk test (6MWT) distance between baseline and four-weeks. An additional exercise training programme for patients in both groups was initiated and completed between 4 and 12 weeks, to determine the effect of iron repletion compared to placebo treatment in the context of patients undertaking an exercise programme. Additional secondary outcomes include fatigue, physical function, muscle strength, muscle metabolism, quality of life, resting blood pressure, clinical chemistry, safety and harms associated with the iron therapy intervention and the exercise training intervention, and hospitalisations. All outcomes were conducted at baseline, 4, and 12 weeks, with a nested qualitative study, to investigate the experience of living with iron deficiency and intervention acceptability. The cohort have been recruited and baseline assessments undertaken.
Results
Seventy-five individuals were recruited. 44% of the randomised cohort were male, the mean (SD) age was 58 (14) years, and 56% were White. Body mass index was 31 (7) kg/m²; serum ferritin was 59 (45) μg/L, transferrin saturation was 22 (10) %, and haemoglobin was 125 (12) g/L at randomisation for the whole group. Estimated glomerular filtration rate was 35 (12) mL/min/1.73 m² and the baseline 6MWT distance was 429 (174) m.
Conclusion
The results from this study will address a substantial knowledge gap in the effects of intravenous iron therapy, and offer potential clinical treatment options, to improve exercise capacity, physical function, fatigue, and muscle metabolism, for non-dialysis patients with CKD who are iron-deficient but not anaemic. It will also offer insight into the potential novel effects of an 8-week exercise training programme.
Trial registration
EudraCT: 2018-000,144-25 Registered 28/01/2019.
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.

Browsing by Person "Bhandari, Sunil"

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