Browsing by Person "Burton, James O."

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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.
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).
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.