The number of people living with multiple long-term conditions (MLTCs or ‘multimorbidity’) is growing. Evidence indicates that exercise-based rehabilitation can improve health-related quality of life and reduce hospital admissions for a number of single long-term conditions. However, it is increasingly recognised that such condition-focused rehabilitation programmes do not meet the needs of people living with MLTCs. The aims for this study were to (1) evaluate the acceptability and feasibility of the newly developed Personalised Exercise Rehabilitation FOR people with Multiple long-term conditions (PERFORM) intervention; (2) assess the feasibility of study methods to inform progression to a definitive randomised controlled trial (RCT) and (3) refine our intervention programme theory.

Semi-structured qualitative interviews were conducted with patients receiving and healthcare practitioners delivering the PERFORM intervention, to seek their experiences of the intervention and taking part in the study. Interviews were analysed thematically, informed by Normalisation Process Theory and the programme theory.

Three UK sites (two acute hospital settings, one community-based healthcare setting).

18 of the 60 PERFORM participants and 6 healthcare professionals were interviewed.

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

All participants and staff interviewed found PERFORM useful for physical and mental well-being and noted positive impacts of participation, although some specific modifications to the intervention delivery and training and study methods were identified. Scheduling, staffing and space limitations were barriers that must be considered for future evaluation and implementation. Key intervention mechanisms identified were social support, patient education, building routines and habits, as well as support from healthcare professionals.

We found the PERFORM intervention to be acceptable and feasible, with the potential to improve the health and well-being of people with MLTCs. The findings of the process evaluation inform the future delivery of the PERFORM intervention and the design of our planned full RCT. A definitive trial is needed to assess the clinical and cost-effectiveness.

ISRCTN68786622.

Existing exercise-based rehabilitation services, such as cardiac and pulmonary rehabilitation, are traditionally commissioned around single long-term conditions (LTCs) and therefore may not meet the complex needs of adults with multiple long-term conditions (MLTCs) or multimorbidity. The aim of this study was to assess the feasibility and acceptability of the newly developed personalised exercise-rehabilitation programme for people with multiple long-term conditions (PERFORM) and the trial methods.

A parallel two-group mixed-methods feasibility randomised controlled trial (RCT) with embedded process and economic evaluation.

Three UK sites (two acute hospital settings, one community-based healthcare setting).

60 adults with MLTCs (defined as the presence of ≥2 LTCs) with at least one known to benefit from exercise therapy were randomised 2:1 to PERFORM intervention plus usual care (PERFORM group) or usual care alone (control group).

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

Primary feasibility outcomes included: trial recruitment (percentage of a target of 60 participants recruited within 4.5 months), retention (percentage of participants with complete EuroQol data at 3 months) and intervention adherence (percentage of intervention group attending ≥60% sessions). Other feasibility measures included completion of outcome measures at baseline (pre-randomisation), 3 months post-randomisation (including patient-reported outcomes, exercise capacity and collection of health and social care resource use) and intervention fidelity.

Target recruitment (40 PERFORM group, 20 control group) was met within the timeframe. Participants were 57% women with a mean (SD) age of 62 (13) years, body mass index of 30.8 (8.0) kg/m² and a median of 4 LTCs (most common: diabetes (41.7%), hypertension (38.3%), asthma (36.7%) and a painful condition (35.0%)). We achieved EuroQol outcome retention of 76.7% (95% CI: 65.9% to 87.1%; 46/60 participants) and intervention adherence of 72.5% (95% CI: 56.3% to 84.4%; 29/40 participants). Data completion for attendees was over 90% for 11/18 outcome measures.

Our findings support the feasibility and rationale for delivering the PERFORM comprehensive self-management and exercise-based rehabilitation intervention for people living with MLTCs and progression to a full multicentre RCT to formally assess clinical effectiveness and cost-effectiveness.

ISRCTN68786622.

SARS-CoV-2 is now endemic and expected to remain a health threat, with new variants continuing to emerge and the potential for vaccines to become less effective. While effective vaccines and natural immunity have significantly reduced hospitalisations and the need for critical care, outpatient treatment options remain limited, and real-world evidence on their clinical and cost-effectiveness is lacking. In this paper, we present the design of the Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID). By evaluating multiple treatment options in a pragmatic adaptive platform trial, this study will generate high-quality, generalisable evidence to inform clinical guidelines and healthcare decision-making.

CanTreatCOVID is an open-label, individually randomised, multicentre, national adaptive platform trial designed to evaluate the clinical and cost-effectiveness of therapeutics for non-hospitalised SARS-CoV-2 patients across Canada. Eligible participants must present with symptomatic SARS-CoV-2 infection, confirmed by PCR or rapid antigen testing (RAT), within 5 days of symptom onset. The trial targets two groups that are expected to be at higher risk of more severe disease: (1) individuals aged 50 years and older and (2) those aged 18–49 years with one or more comorbidities. CanTreatCOVID uses numerous approaches to recruit participants to the study, including a multifaceted public communication strategy and outreach through primary care, outpatient clinics and emergency departments. Participants are randomised to receive either usual care, including supportive and symptom-based management, or an investigational therapeutic selected by the Canadian COVID-19 Outpatient Therapeutics Committee. The first therapeutic arm evaluates nirmatrelvir/ritonavir (Paxlovid), administered two times per day for 5 days. The second therapeutic arm investigates a combination antioxidant therapy (selenium 300 µg, zinc 40 mg, lycopene 45 mg and vitamin C 1.5 g), administered for 10 days. The primary outcome is all-cause hospitalisation or death within 28 days of randomisation.

The CanTreatCOVID master protocol and subprotocols have been approved by Health Canada and local research ethics boards in the participating provinces across Canada. The results of the study will be disseminated to policy-makers, presented at conferences and published in peer-reviewed journals to ensure that findings are accessible to the broader scientific and medical communities. This study was approved by the Unity Health Toronto Research Ethics Board (#22-179) and Clinical Trials Ontario (Project ID 4133).

NCT05614349

Many adolescent girls experience body dissatisfaction and have low levels of physical activity. Secondary school physical education (PE) offers opportunities for girls to build self-confidence and stay active; however, PE uniforms can be a barrier to participation.

To explore how secondary school PE uniform policies influence body image attitudes and PE engagement (participation and enjoyment) among adolescent girls, and how these policies could be co-developed in future.

A qualitative study involving focus groups and interviews.

Forty-four 12–13 year-old girls and six PE staff members from six mixed-sex secondary schools in England.

Using topic guides and participatory activities to aid discussions, we explored PE uniform preferences and the influence on body image attitudes and PE engagement with adolescent girls, as well as the PE uniform policy development process with PE staff. Data were analysed using reflexive thematic analysis, supported by NVivo V.14.

Three themes were generated. Theme 1, ‘Striking the right balance between choice, comfort and uniformity’, describes the challenges of developing PE uniform policies that offer pupils choice to maximise comfort, while maintaining uniformity to ensure smartness, and to reduce social comparison. Theme 2, ‘PE uniforms are "made for boys"’ reflects that current policies can often provide unisex uniforms that do not fit the female body, or gendered options that limit girls’ choices over style and fit. Theme 3, ‘Self-confidence influences comfort in wearing PE uniform, and in turn PE engagement’ suggests girls with high self-confidence may be less concerned about others’ opinions and how they look, leading to greater PE enjoyment, whereas girls with lower self-confidence described feeling self-conscious, especially in communal changing rooms, which could impact their comfort and PE engagement.

Our findings suggest that developing PE uniform policies, which allow pupils to choose their own bottoms, wear additional layers and wear PE uniform all day may improve comfort and inclusivity among girls, facilitating better PE engagement.

Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer.

A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT).

This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval.

Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).

The cardiovascular (circulatory) system is a closed-loop system. The dynamic interaction of the heart and vascular system plays a pivotal role in maintaining adequate cardiac output. Heart failure (HF) is commonly described as a problem of the pump, that is, mechanical myocardial failure causing poor perfusion to the body. Still, the contribution of the vasculature is often neglected. Acute decompensated heart failure (ADHF) carries a poor prognosis and is often accompanied by concomitant chronic kidney disease (CKD) and acute kidney injury (AKI), which inevitably lead to adverse outcomes. The interaction of the heart with the vasculature is conceptualised as ventricular–vascular (arterial) coupling. Arterial stiffness, a non-traditional risk factor for cardiovascular disease, can be measured non-invasively using carotid–femoral pulse wave velocity (cf-PWV). High cf-PWV values mimicking increased arterial stiffness could be a causational factor towards precipitating ADHF or AKI. This study aims to assess whether cf-PWV is higher during the hospitalisation phase of patients with HF (ADHF) and CKD (AKI in CKD) compared with stable compensated HF and stable CKD.

This prospective non-randomised observational study aims to recruit 120 patients aged≥60 years. Arterial stiffness will be assessed in three groups. These groups are decompensated HF with reduced ejection fraction (n=40), decompensated HF with preserved ejection fraction (n=40) and AKI in CKD stage 3a, 3b and 4, n=40. After 4 weeks from hospital discharge, patients in a stable, compensated state will be asked to attend a follow-up clinic visit to repeat the cf-PWV measurement. The primary outcome measure is variation in cf-PWV during hospitalisation against follow-up.

Ethical approval was granted in October 2021 (REC reference 21/EM/0239), recruitment started in February 2022 and the results are expected in late 2025. The findings will be published in peer-reviewed journals.

NCT05012722.