Focal bone lesions are one of the strongest independent predictors of poor prognosis for people with multiple myeloma (MM). Preclinical evidence has shown mechanical load-induced changes in bone cell activity through bone-targeted exercises can delay osteolytic bone metastases. Whether bone-targeted exercises can improve bone health in people with MM, where bone pain, lesions, and fractures are common, requires investigation. This trial aims to determine the effect of bone-targeted exercises on the bone health of people with MM.
People with MM (n=78) will be randomised to an exercise (EX) or control (CON) group. The EX group will perform two supervised and one unsupervised session of individualised, bone-targeted exercise training weekly for 9 months. The CON group will continue receiving standard care and maintain their current physical activity levels. Primary (bone density and microarchitecture) and secondary (bone pain, quality of life, fatigue, physical function, psychological constructs, gut microbiome, disease response, and biomarkers of bone health, immune function, and disease progression) outcomes will be assessed at baseline, 3-, and 9-months. Adverse events, attendance, and adherence will be monitored and cost-effectiveness analysis performed. Linear mixed models will examine group by time differences for all variables of interest. Data will be analysed on an intention-to-treat basis. Semi-structured interviews will be conducted and coded to determine the experiences of participants and the perceived benefits and barriers of the intervention.
The findings of this study will identify whether bone-targeted exercise is safe, feasible, and can improve bone health in people with MM. Furthermore, this study will provide evidence of the effects of bone-targeted exercise on common MM- and treatment-related side-effects, as well as the potential mechanisms underpinning these effects. Collectively, this novel study will identify the potential role of exercise as an adjuvant therapy for the management of bone and psychosocial health for people with MM.