METHODS: In this single-arm pilot study, N = 20 participants diagnosed with MGUS or SMM were allocated to receive a 16-week progressive exercise programme. Primary outcome measures were feasibility and safety. Secondary outcomes were pre- to post-exercise training changes to blood biomarkers of MGUS and SMM disease activity- monoclonal (M)-protein and free light chains (FLC)- plus cardiorespiratory and functional fitness, body composition, quality of life, blood immunophenotype, and blood biomarkers of inflammation.
RESULTS: Fifteen (3 MGUS and 12 SMM) participants completed the exercise programme. Adherence was 91 ± 11%. Compliance was 75 ± 25% overall, with a notable decline in compliance at intensities > 70% V̇O2PEAK. There were no serious adverse events. There were no changes to M-protein (0.0 ± 1.0 g/L, P =.903), involved FLC (+ 1.8 ± 16.8 mg/L, P =.839), or FLC difference (+ 0.2 ± 15.6 mg/L, P =.946) from pre- to post-exercise training. There were pre- to post-exercise training improvements to diastolic blood pressure (- 3 ± 5 mmHg, P =.033), sit-to-stand test performance (+ 5 ± 5 repetitions, P =.002), and energy/fatigue scores (+ 10 ± 15%, P =.026). Other secondary outcomes were unchanged.
CONCLUSIONS: A 16-week progressive exercise programme was feasible and safe, but did not reverse MGUS/SMM disease activity, contrasting a prior case study showing that five years of exercise training reversed SMM in a 44-year-old former athlete. Longer exercise interventions should be explored in a group of MGUS/SMM patients, with measurements of disease biomarkers, along with rates of disease progression (i.e., MGUS/SMM to MM).
BACKGROUND: https://www.isrctn.com/ISRCTN65527208 (14/05/2018).
方法:在这项单臂试点研究中,N=20名诊断为MGUS或SMM的参与者被分配接受16周的渐进式锻炼计划。主要结果指标是可行性和安全性。次要结果是运动训练前后MGUS和SMM疾病活动的血液生物标志物的变化-单克隆(M)蛋白和游离轻链(FLC)-加上心肺和功能适应性。身体成分,生活质量,血液免疫表型,和炎症的血液生物标志物。
结果:15名(3名MGUS和12名SMM)参与者完成了锻炼计划。依从性为91±11%。总体合规性为75±25%,在强度>70%时,依从性显着下降。无严重不良事件发生。M蛋白无变化(0.0±1.0g/L,P=.903),涉及FLC(+1.8±16.8mg/L,P=.839),或FLC差异(+0.2±15.6mg/L,P=.946)从运动前训练到运动后训练。运动前后训练对舒张压有改善(-3±5mmHg,P=.033),坐立试验性能(+5±5次重复,P=.002),和能量/疲劳评分(+10±15%,P=.026)。其他次要结果没有变化。
结论:16周的渐进式锻炼计划是可行且安全的,但没有逆转MGUS/SMM疾病活动,与先前的案例研究相比,该案例研究表明,五年的运动训练逆转了一名44岁的前运动员的SMM。应在一组MGUS/SMM患者中探索更长的运动干预措施,通过测量疾病生物标志物,以及疾病进展率(即,MGUS/SMM到MM)。
背景:https://www.isrctn.com/ISRCTN65527208(2018年5月14日)。