RESUMEN
BACKGROUND: Autologous stem cell transplant (ASCT) is first line treatment for newly diagnosed patients with myeloma but often results in functional deficits and reduced quality of life (QOL). Physically active myeloma patients have better QOL, less fatigue and reduced morbidity. This trial aimed to investigate the feasibility of a physiotherapist-led exercise intervention delivered across the continuum of the myeloma ASCT pathway at a UK centre. Initially designed and delivered as a face-to-face trial, the study protocol was adapted to virtual delivery in response to the COVID-19 pandemic. MATERIAL AND METHODS: A pilot randomised controlled trial of a partly supervised exercise intervention with incorporated behaviour change techniques delivered before, during and for 3 months following ASCT compared to usual care. Face-to-face delivery of the pre-ASCT supervised intervention was adapted to virtually-supervised group classes via video conferencing. Primary outcomes related to feasibility; recruitment rate, attrition and adherence. Secondary outcomes included patient reported measures of QOL (EORTC C30, FACT-BMT, EQ5D), and fatigue (FACIT-F), measures of functional capacity (six-minute walk test (6MWT), timed sit-to-stand (TSTS), hand grip strength, self-reported and objective physical activity (PA). RESULTS: Over 11 months 50 participants were enrolled and randomised. Overall, uptake to the study was 46%. The attrition rate was 34%, mainly related to failure to undergo ASCT. Loss of follow-up for other reasons was low. Secondary outcomes demonstrate potential for the benefit of exercise prior to, during and after ASCT with improvements in QOL, fatigue, functional capacity and PA evident on admission for ASCT and 3 months post-ASCT. DISCUSSION: Results indicate acceptability and feasibility of delivering exercise prehabilitation, in person and virtually within the ASCT pathway in myeloma. The effects of prehabilitation and rehabilitation provision as a component of the ASCT pathway warrants further investigation.
RESUMEN
INTRODUCTION AND OBJECTIVE: Research activity was impacted by the novel COVID-19 pandemic, the PERCEPT myeloma trial was no exception. This pilot randomised trial delivered a face-to-face exercise intervention prior to and during autologous stem cell transplantation (ASCT) in myeloma patients, as a consequence of COVID-19 it required significant adaptions to continue. This brief communication describes how the previously published study protocol was adapted for virtual delivery. In addition, we highlight the challenge of continuing the study which was embedded within a clinical pathway also impacted by the pandemic. SUMMARY: The original trial protocol was amended and continued to recruit and deliver an exercise prehabilitation intervention virtually. Continued delivery of the intervention was deemed important to participants already enrolled within the trial and the adapted virtual version of the trial was acceptable to the research ethics committee as well as participants. Development of effective, remotely delivered rehabilitation and physical activity programmes are likely to benefit people living with myeloma. The COVID-19 pandemic provided an opportunity to explore the feasibility of a virtual programme for ASCT recipients, however, continued changes to the clinical pathway within which the study was embedded posed the greatest challenge and ultimately led to early termination of recruitment. TRIAL REGISTRATION NUMBER: ISRCTN15875290; pre-results.