Normann Amber J, Mo Clifton C, Wilson Rebekah L, Perez Michelle, Cutler Corey, Uno Hajime, Thompson LaDora V, Skinner Tina L, Richardson Paul G, Marinac Catherine R, Dieli-Conwright Christina M
Department of Health Sciences, Sargent College of Health & Rehabilitation Sciences, Boston University, Boston, MA, United States.
Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.
JMIR Res Protoc. 2024 Dec 19;13:e64905. doi: 10.2196/64905.
Muscle mass and strength are severely compromised in patients diagnosed with multiple myeloma, such that the risk of poor overall survival increases as the prevalence of low muscle mass, also known as sarcopenia, increases. Additionally, at the time of autologous stem cell transplant (ASCT), 51% of patients experience low muscle mass and strength, which can prolong hospitalization and lead to increased risk of obesity, insulin resistance, lowered physical function, and poor quality of life.
The PROTECT (Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation) trial will examine the preliminary effects of digitally supervised prehabilitative aerobic and resistance exercise on muscle strength in patients with multiple myeloma scheduled for ASCT.
This prospective, 2-armed single-center randomized controlled trial will recruit 30 patients with multiple myeloma, aged 18 years and older, planning to receive ASCT. Individuals will be assigned to either the exercise or the waitlist control group. The 8-week exercise intervention is home-based and digitally supervised by a clinical exercise trainer. The frequency of the exercise intervention is 3 times per week consisting of aerobic exercise on a cycle ergometer and resistance exercises, which are individually tailored based on patient health status. The waitlist control group maintains normal daily activities of living and is offered the intervention within 6 months from ASCT. The primary outcome is lower limb muscle strength, measured using the 10-repetition maximum leg press or extensor strength. Additional outcomes include physical and cardiorespiratory function, patient-reported outcomes, cardiometabolic health outcomes, and clinical outcomes.
The trial was funded in the fall of 2022 and recruitment began in June 2023. As of August 2024, a total of 3 participants have consented and been randomized (n=1, exercise group; n=2, waitlist control group). Trial completion and start of data analysis is expected in July 2025 with expected results to be published in early winter of 2026.
We expect exercise to improve lower limb muscle strength and overall health outcomes compared to the waitlist control group. Results will contribute foundational knowledge needed to conduct larger-phase clinical trials testing the clinical benefits of prehabilitation exercise in this patient population. This study will provide insight into a prehabilitative exercise intervention designed to support patient prognosis.
ClinicalTrials.gov NCT05706766; https://clinicaltrials.gov/study/NCT05706766.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/64905.
被诊断为多发性骨髓瘤的患者，其肌肉质量和力量会受到严重损害，以至于随着低肌肉质量（即肌肉减少症）患病率的增加，总体生存不良的风险也会上升。此外，在进行自体干细胞移植（ASCT）时，51%的患者存在低肌肉质量和力量的情况，这可能会延长住院时间，并导致肥胖、胰岛素抵抗、身体功能下降和生活质量变差的风险增加。
“保护”（PROTECT，针对接受自体干细胞移植的多发性骨髓瘤患者的术前康复运动训练）试验将研究数字监督下的术前有氧和抗阻运动对计划接受ASCT的多发性骨髓瘤患者肌肉力量的初步影响。
这项前瞻性、双臂单中心随机对照试验将招募30名18岁及以上计划接受ASCT的多发性骨髓瘤患者。个体将被分配到运动组或等候名单对照组。为期8周的运动干预以家庭为基础，并由临床运动训练师进行数字监督。运动干预频率为每周3次，包括在自行车测力计上进行有氧运动和抗阻运动，这些运动根据患者健康状况进行个性化定制。等候名单对照组维持正常的日常活动，并在ASCT后6个月内接受干预。主要结局是下肢肌肉力量，使用10次重复最大腿部推举或伸肌力量进行测量。其他结局包括身体和心肺功能、患者报告的结局、心脏代谢健康结局和临床结局。
该试验于2022年秋季获得资助，2023年6月开始招募。截至2024年8月，共有3名参与者同意并被随机分组（运动组1人；等候名单对照组2人）。预计试验将于2025年7月完成并开始数据分析，预期结果将于2026年初冬发表。
我们预计与等候名单对照组相比，运动能改善下肢肌肉力量和整体健康结局。研究结果将为开展更大规模临床试验提供所需的基础知识，以测试术前康复运动对该患者群体的临床益处。本研究将为旨在支持患者预后的术前康复运动干预提供见解。
ClinicalTrials.gov NCT05706766；https://clinicaltrials.gov/study/NCT05706766。
国际注册报告识别码（IRRID）：DERR1-10.2196/64905。
