Abstract
BackgroundThe study evaluated the feasibility and safety of the exercise intervention and physical test procedures of our ongoing randomized controlled trial, examining the effect of physical exercise in newly diagnosed patients with multiple myeloma.MethodsPatients are randomized 1:1 to a control group (usual care) or an intervention group (usual care and exercise) by block randomization with stratification of planned treatment, WHO performance status, and study site. The exercise intervention consists of eight supervised exercise sessions combined with home-based exercise over a 10-week period. Bone disease is systematically evaluated to determine limitations regarding physical testing and/or exercise. Feasibility outcome measures were study eligibility, acceptance, and attrition, and furthermore attendance, adherence, tolerability, and safety to the exercise intervention. Additionally, test completion, pain, and adverse events during the physical test procedures were evaluated. Outcome assessors were blinded to allocation.ResultsOf 49 patients screened, 30 were included. The median age was 69 years, range 38–90, 77% were males, and 67% had bone disease. Study eligibility was 82%, acceptance 75%, and attrition 20%. Attendance at supervised exercise sessions was 92%, and adherence to supervised exercise sessions and home-based exercise sessions was 99% and 89%, respectively. No serious adverse events attributed to exercise or physical tests were reported. All patients completed the physical tests, except for two patients, where physical test procedures were modified due to bone disease.DiscussionThe exercise intervention and physical test procedures were feasible and safe in patients with multiple myeloma, even in older patients with multiple myeloma and in patients with myeloma bone disease.Trial registrationClinicalTrials.gov. ID NCT02439112. Registered on May 7, 2015.
Highlights
The study evaluated the feasibility and safety of the exercise intervention and physical test procedures of our ongoing randomized controlled trial, examining the effect of physical exercise in newly diagnosed patients with multiple myeloma
The aim of the current study is to evaluate the feasibility and safety of the exercise intervention and physical test procedures
Bone disease in the intervention group was higher than in the control group, but not in whether the bone disease led to any restrictions regarding tests or exercise
Summary
The study evaluated the feasibility and safety of the exercise intervention and physical test procedures of our ongoing randomized controlled trial, examining the effect of physical exercise in newly diagnosed patients with multiple myeloma. Physical exercise in patients with hematological cancer has been shown to be feasible and safe and yielding benefits for aerobic capacity, muscle strength, quality of life (QoL), psychosocial wellbeing, treatment-related symptoms, fatigue, MM is a plasma cell cancer in the bone marrow that primarily affects older adults. At the time of diagnosis, most patients have a symptomatic disease that requires treatment. Pathological fractures, and typically “punched out” lytic lesions are hallmarks of the disease and are present in approximately 80% of the patients at the time of diagnosis and even more during the course of the disease [16]. Painful bone lesions may be treated with radiation therapy, and all patients receive intravenous bisphosphonates to reduce the risk of progressive bone disease, pain, and fractures [18, 19]. Due to the frequent and potentially serious bone involvement, and because MM is a cancer in the older population, the potential role of exercise needs to be investigated separately in patients with MM
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