Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation.

BACKGROUND: UK national clinical guidance recommends that men with prostate cancer on androgen deprivation therapy are offered twice weekly supervised aerobic and resistance exercise to address iatrogenic harm caused by treatment. Very few NHS trusts have established adequate provision of such services. Furthermore, interventions fail to demonstrate sustained behaviour change. The STAMINA lifestyle intervention offers a system-level change to clinical care delivery addressing barriers to long-term behaviour change and implementation of new prostate cancer care pathways. This trial aims to establish whether STAMINA is clinically and cost-effective in improving cancer-specific quality of life and/or reducing fatigue compared to optimised usual care. The process evaluation aims to inform the interpretation of results and, if the intervention is shown to benefit patients, to inform the implementation of the intervention into the NHS. METHODS: Men with prostate cancer on androgen deprivation therapy (n = 697) will be identified from a minimum of 12 UK NHS trusts to participate in a multi-centre, two-arm, individually randomised controlled trial. Consenting men will have a 'safety to exercise' check and be randomly allocated (5:4) to the STAMINA lifestyle intervention (n = 384) or optimised usual care (n = 313). Outcomes will be collected at baseline, 3-, 6- and 12-month post-randomisation. The two primary outcomes are cancer-specific quality of life and fatigue. The parallel process evaluation will follow a mixed-methods approach to explore recruitment and aspects of the intervention including, reach, fidelity, acceptability, and implementation. An economic evaluation will estimate the cost-effectiveness of the STAMINA lifestyle intervention versus optimised usual care and a discrete choice experiment will explore patient preferences. DISCUSSION: The STAMINA lifestyle intervention has the potential to improve quality of life and reduce fatigue in men on androgen deprivation therapy for prostate cancer. Embedding supervised exercise into prostate cancer care may also support long-term positive behaviour change and reduce adverse events caused by treatment. Findings will inform future clinical care and could provide a blueprint for the integration of supervised exercise and behavioural support into other cancer and/or clinical services. TRIAL REGISTRATION: ISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.

Improved clinical outcomes in response to a 12-week blended digital and community-based long-COVID-19 rehabilitation programme.

Introduction: Two million people in the UK are experiencing long COVID (LC), which necessitates effective and scalable interventions to manage this condition. This study provides the first results from a scalable rehabilitation programme for participants presenting with LC. Methods: 601 adult participants with symptoms of LC completed the Nuffield Health COVID-19 Rehabilitation Programme between February 2021 and March 2022 and provided written informed consent for the inclusion of outcomes data in external publications. The 12-week programme included three exercise sessions per week consisting of aerobic and strength-based exercises, and stability and mobility activities. The first 6 weeks of the programme were conducted remotely, whereas the second 6 weeks incorporated face-to-face rehabilitation sessions in a community setting. A weekly telephone call with a rehabilitation specialist was also provided to support queries and advise on exercise selection, symptom management and emotional wellbeing. Results: The 12-week rehabilitation programme significantly improved Dyspnea-12 (D-12), Duke Activity Status Index (DASI), World Health Orginaisation-5 (WHO-5) and EQ-5D-5L utility scores (all p < 0.001), with the 95% confidence intervals (CI) for the improvement in each of these outcomes exceeding the minimum clinically important difference (MCID) for each measure (mean change [CI]: D-12: -3.4 [-3.9, -2.9]; DASI: 9.2 [8.2, 10.1]; WHO-5: 20.3 [18.6, 22.0]; EQ-5D-5L utility: 0.11 [0.10, 0.13]). Significant improvements exceeding the MCID were also observed for sit-to-stand test results (4.1 [3.5, 4.6]). On completion of the rehabilitation programme, participants also reported significantly fewer GP consultations (p < 0.001), sick days (p = 0.003) and outpatient visits (p = 0.007) during the previous 3 months compared with baseline. Discussion: The blended and community design of this rehabilitation model makes it scalable and meets the urgent need for an effective intervention to support patients experiencing LC. This rehabilitation model is well placed to support the NHS (and other healthcare systems worldwide) in its aim of controlling the impacts of COVID-19 and delivering on its long-term plan. Clinical trial registration: https://www.isrctn.com/ISRCTN14707226, identifier 14707226.

A scalable 12-week exercise and education programme reduces symptoms and improves function and wellbeing in people with hip and knee osteoarthritis.

Introduction: Osteoarthritis is a chronic musculoskeletal condition that impacts more than 300 million people worldwide, with 43 million people experiencing moderate to severe disability due to the disease. This service evaluation provides the results from a tailored blended model of care on joint health, physical function, and personal wellbeing. Methods: 1,593 adult participants with osteoarthritis completed the Nuffield Health Joint Pain Programme between February 2019 and May 2022. The 12-week programme included two 40-min exercise sessions per week. All exercise sessions were conducted face-to-face and were followed by 20 min of education to provide information and advice on managing osteoarthritis. Results: The 12-week joint pain programme significantly improved Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) global scores (Week 0: 37.5 [17.2]; Week 12: 24.0 [16.6]; p < 0.001), as well as subscales for pain (Week 0: 7.6 [3.7]; Week 12: 4.9 [3.7]; p < 0.001), function (Week 0: 26.0 [13.0]; Week 12: 16.3 [12.4]; p < 0.001), and stiffness (Week 0: 3.9 [1.6]; Week 12: 2.8 [1.7]; p < 0.001). Significant improvements in health-related outcomes including systolic and diastolic blood pressure (Week 0: 139 [18] mmHg; Week 12: 134 [17] mmHg, and Week 0: 82 [11] mmHg; Week 12: 79 [19] mmHg; both p < 0.001), body mass index (Week 0: 29.0 [4.5] kg/m2; Week 12: 28.6 [4.4] kg/m2; p < 0.001), waist to hip ratio (Week 0: 0.92 [0.23]; Week 12: 0.90 [0.11], p < 0.01) and timed up and go (Week 0: 10.8 s [2.9]; Week 12: 8.1 s [2.0]; p < 0.001) were also observed. On completion of the joint pain programme, participants also reported significant improvements in all assessed aspects of self-reported wellbeing (all p < 0.001). Discussion: With reductions in physical symptoms of osteoarthritis and improvements in personal wellbeing, the joint pain programme delivered by personal trainers in a gym-setting offers a nationally scalable, non-pharmacological treatment pathway for osteoarthritis.

Patient-rated satisfaction and improvement following hip and knee replacements: Development of prediction models.

RATIONALE: Effective preoperative assessments of determinants of health status and function may improve postoperative outcomes. AIMS AND OBJECTIVES: We developed risk scores of preoperative patient factors and patient-reported outcome measures (PROMs) as predictors of patient-rated satisfaction and improvement following hip and knee replacements. PATIENTS AND METHODS: Prospectively collected National Health Service and independent sector patient data (n = 30,457), including patients' self-reported demographics, comorbidities, PROMs (Oxford Hip/Knee score (OHS/OKS) and European Quality of Life (EQ5D index and health-scale), were analysed. Outcomes were defined as patient-reported satisfaction and improvement following surgery at 7-month follow-up. Univariable and multivariable-adjusted logistic regressions were undertaken to build prediction models; model discrimination was evaluated with the concordance index (c-index) and nomograms were developed to allow the estimation of probabilities. RESULTS: Of the 14,651 subjects with responses for satisfaction following hip replacements 564 (3.8%) reported dissatisfaction, and 1433 (9.2%) of the 15,560 following knee replacement reported dissatisfaction. A total of 14,662 had responses for perceived improvement following hip replacement (lack of improvement in 391; 2.7%) and 15,588 following knee replacement (lack of improvements in 1092; 7.0%). Patients reporting poor outcomes had worse preoperative PROMs. Several factors, including age, gender, patient comorbidities and EQ5D, were included in the final prediction models: C-indices of these models were 0.613 and 0.618 for dissatisfaction and lack of improvement, respectively, for hip replacement and 0.614 and 0.598, respectively, for knee replacement. CONCLUSIONS: Using easily accessible preoperative patient factors, including PROMs, we developed models which may help predict dissatisfaction and lack of improvement following hip and knee replacements and facilitate risk stratification and decision-making processes.

Evaluating differences in the clinical impact of a free online weight loss programme, a resource-intensive commercial weight loss programme and an active control condition: a parallel randomised controlled trial.

BACKGROUND: Finding effective intervention strategies to combat rising obesity levels could significantly reduce the burden that obesity and associated non-communicable diseases places on both individuals and the National Health Service. METHODS: In this parallel randomised-controlled trial, 76 participants who are overweight or obese (50 female) were given free access to a fitness centre for the duration of the 12-week intervention and randomised to one of three interventions. The commercial intervention, the Healthy Weight Programme, (HWP, n = 25, 10/15 men/women) consisted of twelve 1-h nutrition coaching sessions with a nutritionist delivered as a mixture of group and 1 to 1 sessions. In addition, twice-weekly exercise sessions (24 in total) were delivered by personal trainers for 12 weeks. The NHS intervention (n = 25, 8/17 men/women) consisted of following an entirely self-managed 12-week online NHS resource. The GYM intervention (n = 26, 8/18 men/women) received no guidance or formal intervention. All participants were provided with a gym induction for safety and both the NHS and GYM participants were familiarised with ACSM physical activity guidelines by way of a hand-out. RESULTS: The overall follow-up rate was 83%. Body mass was significantly reduced at post-intervention in all groups (HWP: N = 18, - 5.17 ± 4.22 kg, NHS: N = 21-4.19 ± 5.49 kg; GYM: N = 24-1.17 ± 3.00 kg; p < 0.001) with greater reductions observed in HWP and NHS groups compared to GYM (p < 0.05). Out with body mass and BMI, there were no additional statistically significant time x intervention interaction effects. CONCLUSIONS: This is the first study to evaluate the efficacy of both a free online NHS self-help weight-loss tool and a commercial weight loss programme that provides face-to-face nutritional support and supervised exercise. The findings suggest that both interventions are superior to an active control condition with regard to eliciting short-term weight-loss. TRIAL REGISTRATION: ISRCTN Registry - ISRCTN31489026. Prospectively registered: 27/07/16.