BiCyCLE NMES—neuromuscular electrical stimulation in the perioperative treatment of sarcopenia and myosteatosis in advanced rectal cancer patients: design and methodology of a phase II randomised controlled trial

Abstract: Background: Colorectal cancer is associated with secondary sarcopenia (muscle loss) and myosteatosis (fatty infiltration of muscle) and patients who exhibit these host characteristics have poorer outcomes following surgery. Furthermore, patients, who undergo curative advanced rectal cancer surgery such as pelvic exenteration, are at risk of skeletal muscle loss due to immobility, malnutrition and a post-surgical catabolic state. Neuromuscular electrical stimulation (NMES) may be a feasible adjunctive treatment to help ameliorate these adverse side-effects. Hence, the purpose of this study is to investigate NMES as an adjunctive pre- and post-operative treatment for rectal cancer patients in the radical pelvic surgery setting and to provide early indicative evidence of efficacy in relation to key health outcomes. Method: In a phase II, double-blind, randomised controlled study, 58 patients will be recruited and randomised (1:1) to either a treatment (NMES plus standard care) or placebo (sham-NMES plus standard care) group. The intervention will begin 2 weeks pre-operatively and continue for 8 weeks after exenterative surgery. The primary outcome will be change in mean skeletal muscle attenuation, a surrogate marker of myosteatosis. Sarcopenia, quality of life, inflammatory status and cancer specific outcomes will also be assessed. Discussion: This phase II randomised controlled trial will provide important preliminary evidence of the potential for this adjunctive treatment. It will provide guidance on subsequent development of phase 3 studies on the clinical benefit of NMES for rectal cancer patients in the radical pelvic surgery setting. Trial registration: Protocol version 6.0; 05/06/20. ClinicalTrials.gov NCT04065984. Registered on 22 August 2019; recruiting

Exploration of therapists’ views of practice within critical care

Introduction Therapists are increasing recognised as core members of the critical care multiprofessional team. Each therapy profession provides specialist assessments and interventions, but also work collaboratively across the rehabilitation pathway. Despite inclusion in several national guidance documents, there remains a lack of evidence regarding the perceived role of therapists working within critical care, the unique contributions of each profession and opinion on the day-to-day tasks and responsibilities of each therapy profession. Method A descriptive qualitative methodology was used involving seven focus groups. Purposeful sampling was used to recruit therapists via professional specialist interest groups. All focus groups were uniprofessional and discussions based on a predesigned framework. Data were analysed thematically. Results Participants (n=65) from across the UK were recruited to seven focus groups with an average of 18.3 years postgraduate clinical experience of which 11.6 years was within critical care. Three core themes were generated from 875 codes and 237 potential subthemes. The final themes were (1) professional characteristics; (2) multidisciplinary team and (3) staffing. An additional theme of ‘COVID-19 pandemic’ was also identified. Findings were similar across all profession groups particularly regarding the need for holistic, patient-centred care. Expected variation was observed for professional characteristics especially regarding specific assessments and interventions. Discussion Therapy services are an essential component to the delivery of critical care especially regarding recovery and rehabilitation. Through three core themes, this qualitative study has provided new evidence of the perceptions and opinions of the role that therapists undertake within critical care