Exercise Therapy for Chronic Symptomatic Peripheral Artery Disease: A Clinical Consensus Document of the European Society of Cardiology Working Group on Aorta and Peripheral Vascular Diseases in Collaboration With the European Society of Vascular Medicine and the European Society for Vascular Surgery.

All guidelines worldwide strongly recommend exercise as a pillar in the management of patients affected by lower extremity peripheral artery disease (PAD). Exercise therapy in this setting presents different modalities, and a structured programme provides optimal results. This clinical consensus paper is intended to promote and assist the set up of comprehensive exercise programmes and best advice for patients with symptomatic chronic PAD. Different exercise training protocols specific for patients with PAD are presented. Data on patient assessment and outcome measures are described based on the current best evidence. The document ends by highlighting supervised exercise programme access disparities across Europe and the evidence gaps requiring further research.

International consensus is needed on a core outcome set to advance the evidence of best practice in cancer prehabilitation services and research.

Prehabilitation aims to optimise patients' physical and psychological status before treatment. The types of outcomes measured to assess the impact of prehabilitation interventions vary across clinical research and service evaluation, limiting the ability to compare between studies and services and to pool data. An international workshop involving academic and clinical experts in cancer prehabilitation was convened in May 2022 at Sheffield Hallam University's Advanced Wellbeing Research Centre, England. The workshop substantiated calls for a core outcome set to advance knowledge and understanding of best practice in cancer prehabilitation and to develop national and international databases to assess outcomes at a population level.

Exercise therapy for chronic symptomatic peripheral artery disease.

All guidelines worldwide strongly recommend exercise as a pillar of the management of patients affected by lower extremity peripheral artery disease (PAD). Exercise therapy in this setting presents different modalities, and a structured programme provides optimal results. This clinical consensus paper is intended for clinicians to promote and assist for the set-up of comprehensive exercise programmes to best advice in patients with symptomatic chronic PAD. Different exercise training protocols specific for patients with PAD are presented. Data on patient assessment and outcome measures are narratively described based on the current best evidence. The document ends by highlighting disparities in access to supervised exercise programmes across Europe and the series of gaps for evidence requiring further research.

Exercise therapy for chronic symptomatic peripheral artery disease.

All guidelines worldwide strongly recommend exercise as a pillar in the management of patients affected by lower extremity peripheral artery disease (PAD). Exercise therapy in this setting presents different modalities, and a structured programme provides optimal results. This clinical consensus paper is intended to promote and assist the set up of comprehensive exercise programmes and best advice for patients with symptomatic chronic PAD. Different exercise training protocols specific for patients with PAD are presented. Data on patient assessment and outcome measures are described based on the current best evidence. The document ends by highlighting supervised exercise programme access disparities across Europe and the evidence gaps requiring further research.

Supporting physical activity through co-production in people with severe mental ill health (SPACES): protocol for a randomised controlled feasibility trial.

BACKGROUND: Severe mental ill health (SMI) includes schizophrenia, bipolar disorder and schizoaffective disorder and is associated with premature deaths when compared to people without SMI. Over 70% of those deaths are attributed to preventable health conditions, which have the potential to be positively affected by the adoption of healthy behaviours, such as physical activity. People with SMI are generally less active than those without and face unique barriers to being physically active. Physical activity interventions for those with SMI demonstrate promise, however, there are important questions remaining about the potential feasibility and acceptability of a physical activity intervention embedded within existing NHS pathways. METHOD: This is a two-arm multi-site randomised controlled feasibility trial, assessing the feasibility and acceptability of a co-produced physical activity intervention for a full-scale trial across geographically dispersed NHS mental health trusts in England. Participants will be randomly allocated via block, 1:1 randomisation, into either the intervention arm or the usual care arm. The usual care arm will continue to receive usual care throughout the trial, whilst the intervention arm will receive usual care plus the offer of a weekly, 18-week, physical activity intervention comprising walking and indoor activity sessions and community taster sessions. Another main component of the intervention includes one-to-one support. The primary outcome is to investigate the feasibility and acceptability of the intervention and to scale it up to a full-scale trial, using a short proforma provided to all intervention participants at follow-up, qualitative interviews with approximately 15 intervention participants and 5 interventions delivery staff, and data on intervention uptake, attendance, and attrition. Usual care data will also include recruitment and follow-up retention. Secondary outcome measures include physical activity and sedentary behaviours, body mass index, depression, anxiety, health-related quality of life, healthcare resource use, and adverse events. Outcome measures will be taken at baseline, three, and six-months post randomisation. DISCUSSION: This study will determine if the physical activity intervention is feasible and acceptable to both participants receiving the intervention and NHS staff who deliver it. Results will inform the design of a larger randomised controlled trial assessing the clinical and cost effectiveness of the intervention. TRIAL REGISTRATION: ISRCTN: ISRCTN83877229. Registered on 09.09.2022.

Digital health coaching to improve patient preparedness for elective lower limb arthroplasty: a quality improvement project.

Major surgery carries high risks with comorbidities, frailty and health risk behaviours meaning patients are often unprepared for the physiological insult. Since 2018, the Prepwell programme at South Tees Hospitals NHS Foundation Trust has supported patients to improve their preoperative health and fitness. In April 2020, the face-to-face service was suspended due to the pandemic, leading to the team implementing a three-tiered remote digital support pathway, including digital health coaching via a mobile phone application. METHODS: Patients scheduled for elective lower limb arthroplasty were offered 8 weeks of digital health coaching preoperatively. Following consent, participants were assigned a personal health coach to set individual behaviour change goals supported by online resources, alongside a digitally delivered exercise programme. Participants completed self-assessment questionnaires at Entry to, and Exit from, the programme, with outcome data collected 21 days postoperatively. The primary outcome was the change in Patient Activation Measure (PAM). RESULTS: Fifty-seven of 189 patients (30.2%) consented to referral for digital health coaching. Forty participants completed the 8-week programme. Median PAM increased from 58.1 to 67.8 (p=0.002). Thirty-five per cent of participants were in a non-activated PAM level at Entry, reducing to 15% at Exit with no participants in PAM level 1 at completion. Seventy-one percent of non-activated participants improved their PAM by one level or more, compared with 45% for the whole cohort. Median LOS was 2 days, 1 day less than the Trust's arthroplasty patient population during the study period (unadjusted comparison). CONCLUSIONS: Digital health coaching was successfully implemented for patients awaiting elective lower limb arthroplasty. We observed significant improvements in participants' PAM scores after the programme, with the largest increase in participants with lower activation scores at Entry. Further study is needed to confirm the effects of digital health coaching in this and other perioperative groups.

Towards the standardization of physical activity programs for severe mental ill health: A survey of current practice across 54 mental health trusts in England.

AIMS: While physical activity (PA) is recommended in the treatment of severe mental illness (SMI), there are no standardized processes for implementing PA in mental healthcare, and the extent to which PA programs have been implemented is unknown. Therefore, we sought to describe usual care in terms of the provision of PA in the National Health Service (NHS) mental health trusts in England for people with SMI. METHODS: We invited all NHS Mental Health Trusts across England to participate in a bespoke survey. RESULTS: Fifty-two mental health trusts (96.2%) responded, of which 47 (87%) offered some form of physical activity provision. The provision across these 47 trusts comprised 93 different types of PA programs. The programs that were identified showed vast differences in the types of physical activity offered, the settings in which they were provided, and the providers. CONCLUSIONS: Although existing mental healthcare services are demonstrating good practice in some areas, the findings of this survey underline the pressing need for more standardization of PA programs that are delivered to people with SMI, better allocation of resources, staff training, improved monitoring of the delivery of these programs, and better PA support for patients as they transition to community care.

Exercise Perceptions and Experiences in Adults With Crohn's Disease Following a Combined Impact and Resistance Training Program: A Qualitative Study.

Background: Exercise is increasingly being recognized to counteract specific complications of Crohn's disease (CD). The aim of this study was to explore exercise experiences and perceptions after engaging in a combined impact and resistance training program, involving both intervention and control group viewpoints. Methods: Semistructured telephone interviews, involving a convenience sample of participants with CD (n = 41; aged 49.1 ± 12 years) were undertaken up to 6 weeks following completion of the program. Data were analyzed using thematic analysis. Results: Four overarching themes emerged, along with 11 subthemes: (1) Lack of confidence and knowledge, fears surrounding physical ability and symptoms, coupled with issues not addressed as part of the healthcare pathway played a part in transitioning to inactivity; (2) Improvements in strength, mental well-being, physical fitness, fatigue, abdominal and joint pain, comorbidities, and self-management strategies were among the reported benefits of exercise participation; (3) Seeing progress, goal setting, enjoyment, and a peer-led program receiving support and advice increased motivation. Whereas work-related tiredness, other commitments, and self-directed exercise were reported as exercise barriers; (4) The intervention design was well received and the journey from start to finish was positively discussed, important considerations for future interventions and implementation strategies. Conclusions: The study yielded novel perceptions on the transition to inactivity following receiving a diagnosis, physical and psychological benefits accruing from the intervention, and views on program design. Information that will provide an essential step in the development of implementing exercise guidelines into the clinical pathway and supporting individuals with self-management options.

Physical Activity in Adults with Schizophrenia and Bipolar Disorder: A Large Cross-Sectional Survey Exploring Patterns, Preferences, Barriers, and Motivating Factors.

Adults with severe mental ill health may have specific attitudes toward physical activity. To inform intervention development, we conducted a survey to assess the physical activity patterns, preferences, barriers, and motivations of adults with severe mental ill health living in the community. Data were summarised using descriptive statistics, and logistic regressions were used to explore relationships between physical activity status and participant characteristics. Five-hundred and twenty-nine participants (58% male, mean age 49.3 years) completed the survey. Large numbers were insufficiently active and excessively sedentary. Self-reported levels of physical activity below that recommended in national guidelines were associated with professional inactivity, consumption of fewer than five portions of fruit and vegetables per day, older age, and poor mental health. Participants indicated a preference for low-intensity activities and physical activity that they can do on their own, at their own time and pace, and close to home. The most commonly endorsed source of support was social support from family and friends. Common motivations included improving mental health, physical fitness, and energy levels. However, poor mental and physical health and being too tired were also common barriers. These findings can inform the development of physical activity interventions for this group of people.

Effects of structured exercise programmes on physiological and psychological outcomes in adults with inflammatory bowel disease (IBD): A systematic review and meta-analysis.

BACKGROUND: Exercise has been suggested to counteract specific complications of inflammatory bowel disease (IBD). However, its role as a therapeutic option remains poorly understood. Therefore, we conducted a systematic review and meta-analysis on the effects of exercise in IBD. METHODS: Five databases (MEDLINE, Embase, CINAHL, CENTRAL and SPORTDiscus) and three registers (Clinicaltrials.gov, WHO ICTRP and ISRCTN) were searched from inception to September 2022, for studies assessing the effects of structured exercise of at least 4 weeks duration on physiological and/or psychological outcomes in adults with IBD. Two independent reviewers screened records, assessed risk of bias using the Cochrane Risk of Bias (RoB 2.0) and ROBINS-I tools, and evaluated the certainty of evidence using the GRADE method. Data were meta-analysed using a random-effects model. RESULTS: From 4,123 citations, 15 studies (9 RCTs) were included, comprising of 637 participants (36% male). Pooled evidence from six RCTs indicated that exercise improved disease activity (SMD = -0.44; 95% CI [-0.82 to -0.07]; p = 0.02), but not disease-specific quality of life (QOL) (IBDQ total score; MD = 3.52; -2.00 to 9.04; p = 0.21) when compared to controls. Although meta-analysis could not be performed for other outcomes, benefits were identified in fatigue, muscular function, body composition, cardiorespiratory fitness, bone mineral density and psychological well-being. Fourteen exercise-related non-serious adverse events occurred. The overall certainty of evidence was low for disease activity and very low for HRQOL as a result of downgrading for risk of bias and imprecision. CONCLUSIONS: Structured exercise programmes improve disease activity, but not disease-specific QOL. Defining an optimal exercise prescription and synthesis of evidence in other outcomes, was limited by insufficient well-designed studies to ascertain the true effect of exercise training. This warrants further large-scale randomised trials employing standard exercise prescription to verify this effect to enable the implementation into clinical practice. REGISTRATION: This systematic review was prospectively registered in an international database of systematic reviews in health-related research (CRD42017077992; https://www.crd.york.ac.uk/prospero/).

Preoperative exercise training for adults undergoing elective major vascular surgery: A systematic review.

Patients undergoing major vascular surgery may have an increased risk of postoperative complications due to poor 'fitness for surgery'. Prehabilitation aims to optimise physical fitness and risk factors before surgery to improve outcomes. The role of exercise-based prehabilitation in vascular surgery is currently unclear. Therefore, the aim of this systematic review was to assess the benefits and harms of preoperative exercise training in adults undergoing elective vascular surgery. We searched MEDLINE, Embase, CINAHL, and CENTRAL databases, trial registries, and forward and backward citations for studies published between January 2008 and April 2021. We included randomised trials that compared patients receiving exercise training with those receiving usual care or no training before vascular surgery. Outcomes included mortality, complications, and health-related quality of life (HRQOL). Three trials with 197 participants were included. All studies involved people undergoing abdominal aortic aneurysm (AAA) repair. Low-certainty evidence could not differentiate between rates of all-cause mortality. Moderate-certainty evidence indicated that postoperative cardiac and renal complications were less likely to occur in people who participated in preoperative exercise training compared with those who did not. Low-certainty evidence also indicated better postoperative HRQOL outcomes in people who undertook prehabilitation. There were no serious exercise-related adverse events. The evidence on preoperative exercise training for AAA patients is promising, but currently insufficiently robust for this intervention to be recommended in clinical guidelines. High-quality trials are needed to establish its clinical and cost-effectiveness. Research is also needed to determine the feasibility and effects of prehabilitation before lower-limb revascularisation. Trial registration: PROSPERO ID: CRD42021245933.

Enclosing a pen in a postal questionnaire follow-up to increase response rate: a study within a trial.

Background: Poor response rates to follow-up questionnaires can adversely affect the progress of a randomised controlled trial and the validity of its results. This embedded 'study within a trial' aimed to investigate the impact of including a pen with the postal 3-month questionnaire completed by the trial participants on the response rates to this questionnaire. Methods: This study was a two-armed randomised controlled trial nested in the Gentle Years Yoga (GYY) trial. Participants in the intervention group of the GYY trial were allocated 1:1 using simple randomisation to either receive a pen (intervention) or no pen with their 3-month questionnaire (control). The primary outcome was the proportion of participants sent a 3-month questionnaire who returned it. Secondary outcomes were time taken to return the questionnaire, proportion of participants sent a reminder to return the questionnaire, and completeness of the questionnaire. Binary outcomes were analysed using logistic regression, time to return by Cox Proportional Hazards regression and number of items completed by linear regression. Results: There were 111 participants randomised to the pen group and 118 to the no pen group who were sent a 3-month questionnaire. There was no evidence of a difference in return rates between the two groups (pen 107 (96.4%), no pen 117 (99.2%); OR 0.23, 95% CI 0.02 to 2.19, p=0.20). Furthermore, there was no evidence of a difference between the two groups in terms of time to return the questionnaire (HR 0.90, 95% CI 0.69 to 1.18, p=0.47), the proportion of participants sent a reminder (OR 0.85, 95% CI 0.48 to 1.53, p=0.60) nor the number of items completed (mean difference 0.51, 95% CI -0.04 to 1.06, p=0.07). Conclusion: The inclusion of a pen with the postal 3-month follow-up questionnaire did not have a statistically significant effect on response rate.

An updated systematic review and meta-analysis of home-based exercise programs for individuals with intermittent claudication.

OBJECTIVE: Supervised exercise programs (SEP) are effective for improving walking distance in patients with intermittent claudication (IC) but provision and uptake rates are suboptimal. Access to such programs has also been halted by the Coronavirus pandemic. The aim of this review is to provide a comprehensive overview of the evidence for home-based exercise programs (HEP). METHODS: This review was conducted in according with the published protocol and PRISMA guidance. Medline, EMBASE, CINAHL, PEDro, and Cochrane CENTRAL were searched for terms relating to HEP and IC. Randomized and nonrandomized trials that compared HEP with SEP, basic exercise advice, or no exercise controls for IC were included. A narrative synthesis was provided for all studies and meta-analyses conducted using data from randomized trials. The primary outcome was maximal walking distance. Subgroup analyses were performed to consider the effect of monitoring. Risk of bias was assessed using the Cochrane tool and quality of evidence via GRADE. RESULTS: We included 23 studies with 1907 participants. Considering the narrative review, HEPs were inferior to SEPs which was reflected in the meta-analysis (mean distance [MD], 139 m; 95% confidence interval [CI], 45-232 m; P = .004; very low quality of evidence). Monitoring was an important component, because HEPs adopting this strategy were equivalent to SEPs (MD, 8 m; 95% CI, -81 to 97; P = .86; moderate quality of evidence). For HEPs vs basic exercise advice, narrative review suggested HEPs can be superior, although not always significantly so. For HEPs vs no exercise controls, narrative review and meta-analysis suggested HEPs were potentially superior (MD, 136 m; 95% CI, -2 to 273 m; P = .05; very low quality of evidence). Monitoring was also a key element in these comparisons. Other elements such as appropriate frequency (≥3× a week), intensity (to moderate-maximum pain), duration (20 progressing to 60 minutes) and type (walking) of exercise were important, as was education, self-regulation, goal setting, feedback, and action planning. CONCLUSIONS: When SEPs are unavailable, HEPs are recommended. However, to elicit maximum benefit they should be structured, incorporating all elements of our evidence-based recommendations.

Yoga for older adults with multimorbidity (the Gentle Years Yoga Trial): study protocol for a randomised controlled trial.

BACKGROUND: Multimorbidity is common in older adults and associated with high levels of illness burden and healthcare expenditure. The evidence base for how to manage older adults with multimorbidity is weak. Yoga might be a useful intervention because it has the potential to improve health-related quality of life, physical functioning, and several medical conditions. The British Wheel of Yoga's Gentle Years Yoga© (GYY) programme was developed specifically for older adults, including those with chronic medical conditions. Data from a pilot trial suggested feasibility of using GYY in this population, but its effectiveness and cost-effectiveness remain uncertain. METHODS: This is a multi-site, individually randomised, superiority trial with an embedded process evaluation and an economic analysis of cost-effectiveness. The trial will compare an experimental strategy of offering a 12-week GYY programme against a control strategy of no offer in community-dwelling adults aged 65 or over who have multimorbidity, defined as having two or more chronic conditions from a predefined list. The primary outcome is health-related quality of life measured using the EQ-5D-5L, the primary endpoint being the overall difference over 12 months. Both groups will continue to be able to access their usual care from primary, secondary, community, and social services. Participants, care providers, and yoga teachers will not be blinded to the allocated intervention. Outcome measures are primarily self-reported. The analysis will follow intention-to-treat principles. DISCUSSION: This pragmatic randomised controlled trial will demonstrate if the GYY programme is an effective, cost-effective, and viable addition to the management of older adults with multimorbidity. TRIAL REGISTRATION: ISRCTN ISRCTN13567538 . Registered on 18 March 2019.

Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial.

PURPOSE: To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). METHODS: This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12-15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. RESULTS: There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. CONCLUSION: This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. TRIAL REGISTRATION: ISRCTN10490647.

A 2x2 randomised factorial SWAT of the use of a pen and small, financial incentive to improve recruitment in a randomised controlled trial of yoga for older adults with multimorbidity.

Background: Monetary and other incentives may increase recruitment to randomised controlled trials. Methods: This was a 2x2 factorial 'study within a trial' of including a pen and/or £5 with a postal recruitment pack to improve randomisation rate (primary outcome) into the host Gentle Years Yoga trial in older adults with multimorbidity. Secondary outcomes: return, and time to return, of screening form, and the cost per additional participant recruited. Binary data were analysed using logistic regression and time to return data using Cox proportional hazards regression.  Results: 818 potential host trial participants included. Between those sent a pen (n=409) and not sent a pen (n=409), there was no evidence of a difference in the likelihood of being randomised (15 (3.7%) versus 11 (2.7%); OR 1.38, 95% CI 0.63-3.04), in returning a screening form (66 (16.1%) versus 61 (14.9%); OR 1.10, 95% CI 0.75-1.61) nor in time to return the screening form (HR 1.09, 95% CI 0.77-1.55). There was evidence of improved screening return rates (77 (18.8%) versus 50 (12.2%); OR 1.67, 95% CI 1.13-2.45) and time to return screening form (HR 1.56, 95% CI 1.09-2.22) but not randomisation (14 (3.4%) versus 12 (2.9%); OR 1.18, 95% CI 0.54-2.57) in those sent £5 (n=409) compared with those not sent £5 (n=409). No significant interaction effects between the interventions were observed. The cost per additional participant recruited was £32 for the pen and £1000 for the £5 incentive. Conclusion: Including a small, monetary incentive encouraged increased and faster response to the recruitment invitation but did not result in more participants being randomised into the host trial. Since it is relatively costly, we do not recommend this intervention for use to increase recruitment in this population. Pens are cheaper but did not provide evidence of benefit. Further studies may be required.

Surgical fixation compared with cast immobilisation for adults with a bicortical fracture of the scaphoid waist: the SWIFFT RCT.

BACKGROUND: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Immediate surgical fixation of this fracture has increased. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of surgical fixation with cast treatment and early fixation in adults with scaphoid waist fractures that fail to unite. DESIGN: Multicentre, pragmatic, open-label, parallel two-arm randomised controlled trial with an economic evaluation and a nested qualitative study. SETTING: Orthopaedic departments of 31 hospitals in England and Wales recruited from July 2013, with final follow-up in September 2017. PARTICIPANTS: Adults (aged ≥ 16 years) presenting within 2 weeks of injury with a clear, bicortical fracture of the scaphoid waist on plain radiographs. INTERVENTIONS: Early surgical fixation using Conformité Européenne-marked headless compression screws. Below-elbow cast immobilisation for 6-10 weeks and urgent fixation of confirmed non-union. MAIN OUTCOME MEASURES: The primary outcome and end point was the Patient-Rated Wrist Evaluation total score at 52 weeks, with a clinically relevant difference of 6 points. Secondary outcomes included Patient-Rated Wrist Evaluation pain and function subscales, Short Form questionnaire 12-items, bone union, range of movement, grip strength, complications and return to work. RESULTS: The mean age of 439 participants was 33 years; 363 participants were male (83%) and 269 participants had an undisplaced fracture (61%). The primary analysis was on 408 participants with valid Patient-Rated Wrist Evaluation outcome data for at least one post-randomisation time point (surgery, n = 203 of 219; cast, n = 205 of 220). There was no clinically relevant difference in the Patient-Rated Wrist Evaluation total score at 52 weeks: the mean score in the cast group was 14.0 (95% confidence interval 11.3 to 16.6) and in the surgery group was 11.9 (95% confidence interval 9.2 to 14.5), with an adjusted mean difference of -2.1 in favour of surgery (95% confidence interval -5.8 to 1.6; p = 0.27). The non-union rate was low (surgery group, n = 1; cast group, n = 4). Eight participants in the surgery group had a total of 11 reoperations and one participant in the cast group required a reoperation for non-union. The base-case economic analysis at 52 weeks found that surgery cost £1295 per patient more (95% confidence interval £1084 to £1504) than cast treatment. The base-case analysis of a lifetime-extrapolated model confirmed that the cast treatment pathway was more cost-effective. The nested qualitative study identified patients' desire to have a 'sense of recovering', which surgeons should address at the outset. LIMITATION: There were 17 participants who had initial cast treatment and surgery for confirmed non-union, which in 14 cases was within 6 months from randomisation and in three cases was after 6 months. Three of the four participants in the cast group who had a non-union at 52 weeks were not offered surgery. CONCLUSIONS: Adult patients with an undisplaced or minimally displaced scaphoid waist fracture should have cast immobilisation and suspected non-unions immediately confirmed and urgently fixed. Patients should be followed up at 5 years to investigate the effect of partial union, degenerative arthritis, malunion and screw problems on their quality of life. TRIAL REGISTRATION: Current Controlled Trials ISRCTN67901257. 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. 24, No. 52. See the NIHR Journals Library website for further project information.

Fracture of the scaphoid bone (one of eight small bones in the wrist) is common in young active people. It is caused by a fall on the hand or the hand being suddenly forced backwards. The usual treatment is to rest the wrist in a plaster cast for 6­10 weeks and allow the broken bone to heal. In 1 in 10 cases in which the fracture is treated in a plaster cast, the bone does not heal and an operation is needed. In the operation, the broken bone is held still with a screw. In the last few years, it has become more common to fix the broken bone with a screw in the first few days after injury, instead of resting the wrist in a plaster cast. It is not clear if fixing the bone early with a screw, compared with resting the wrist in a cast, gives better outcomes for patients and if one treatment is better value for money for the NHS. In this study, 439 adult patients agreed either to have surgery to hold the broken scaphoid with a special screw or to have the wrist held still in a plaster cast (with surgery offered after 6 weeks to those who were still not healed). The decision about which treatment to use was made using randomisation, which is similar to tossing a coin. Patients reported their own wrist pain and function at 6, 12, 26 and 52 weeks. Information was also collected on general health, bone healing, grip strength and range of movement, complications from treatment and costs. No important differences were found in patients' wrist pain and function at 52 weeks. The bone did not heal properly in four patients in the surgery group or in nine patients in the plaster cast group at 52 weeks. For one of these patients in the surgery group and four of these patients in the plaster cast group, the bone did not join at all. Eight patients in the surgery group had further surgery following their initial operation to fix their wrist, and one patient in the cast group required repeated surgery because the bone did not join at all. The overall cost of treating with a plaster cast was lower than that of early surgery. Therefore, the findings of the study suggest that a plaster cast should be used initially and that the bone should be immediately fixed with a screw if it does not heal.

Randomised clinical trial: combined impact and resistance training in adults with stable Crohn's disease.

BACKGROUND: Crohn's disease (CD) is a predisposing factor for bone loss and muscle dysfunction, which could lead to osteoporotic fractures and physical disability, respectively. AIM: To assess the effect of 6 months of combined impact and resistance training on bone mineral density (BMD) and muscle function in adults with CD. METHODS: In this randomised controlled trial, 47 adults with stable CD were assigned to exercise (n = 23) or control (n = 24) groups and followed up for 6 months. The exercise group received usual care plus a 6-month combined impact and resistance training programme, involving three, 60-minute sessions per week and a gradual tapering of supervision to self-management. The control group received usual care alone. The primary outcomes were BMD (via dual energy X-ray absorptiometry) and muscle function (measures of upper and lower limb strength and endurance) at 6 months. RESULTS: At 6 months, BMD values were superior in the exercise group with statistical significance at lumbar spine (adjusted mean difference 0.036 g/cm2, 95% CI 0.024-0.048; P < 0.001), but not at femoral neck (0.018 g/cm2, 0.001-0.035; P = 0.059) or greater trochanter (0.013 g/cm2, -0.019 to 0.045; P = 0.415) after correcting for multiple outcomes. The exercise group also had superior values for all muscle function outcomes (P < 0.001; unadjusted mean differences ranging 22.6‒48.2%), and lower fatigue severity (P = 0.005). Three exercise-related adverse events were recorded: two instances of light-headedness and one of nausea. CONCLUSIONS: The intervention improved BMD and muscle function in adults with CD and appears as a suitable model of exercise for reducing future risk of osteoporotic fractures and disability. TRIAL REGISTRATION: ISRCTN11470370.

Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial.

BACKGROUND: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management. The SWIFFT trial compared the clinical effectiveness of surgical fixation with cast immobilisation and early fixation of fractures that fail to unite in adults with scaphoid waist fractures displaced by 2 mm or less. METHODS: This pragmatic, parallel-group, multicentre, open-label, two-arm, randomised superiority trial included adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs. An independent remote randomisation service used a computer-generated allocation sequence with randomly varying block sizes to randomly assign participants (1:1) to receive either early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group). Randomisation was stratified by whether or not there was displacement of either a step or a gap of 1-2 mm inclusive on any radiographic view. The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation, and it was analysed on an available case intention-to-treat basis. This trial is registered with the ISRCTN registry, ISRCTN67901257, and is no longer recruiting, but long-term follow-up is ongoing. FINDINGS: Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men) were randomly assigned to the surgery group (n=219) or to the cast immobilisation group (n=220). Of these, 408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group). 16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks. There was no significant difference in mean PRWE scores at 52 weeks between the surgery group (adjusted mean 11·9 [95% CI 9·2-14·5]) and the cast immobilisation group (14·0 [11·3 to 16·6]; adjusted mean difference -2·1 [95% CI -5·8 to 1·6], p=0·27). More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]). The number of participants who had a medical complication was similar between the two groups (four [2%] in the surgery group and five [2%] in the cast immobilisation group). INTERPRETATION: Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery. This treatment strategy will help to avoid the risks of surgery and mostly limit the use of surgery to fixing fractures that fail to unite. FUNDING: National Institute for Health Research Health Technology Assessment Programme.