Prehabilitation Exercise Training to Target Improved Muscle Strength in Pretransplant Patients Diagnosed With Multiple Myeloma: Protocol for a Pilot Randomized Controlled Trial

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT05706766; https://clinicaltrials.gov/study/NCT05706766.

International registered report identifier (irrid): DERR1-10.2196/64905.