Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 31, 2024
Date Accepted: Sep 13, 2024
Prehabilitation exercise training to target improved muscle strength in pre-transplant patients diagnosed with multiple myeloma: Protocol for a pilot randomized controlled trial
ABSTRACT
Background:
Muscle mass and strength are severely compromised in patients diagnosed with multiple myeloma (MM), 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:
Therefore, the PROTECT Trial will examine preliminary effects of virtually supervised prehabilitative aerobic and resistance exercise on muscle strength in patients with MM scheduled for ASCT.
Methods:
This prospective, two-armed single center randomized controlled trial will recruit 30 patients with MM, ≥18 years old, planning to receive ASCT. Individuals will be assigned to either the exercise or waitlist control group. The 8-week exercise intervention is home-based and virtually supervised by a clinical exercise trainer. The frequency of the exercise intervention is 3x/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 are offered the intervention within six months from ASCT. The primary outcome is lower limb muscle strength, measured utilizing 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 recruitment began in June 2023. As of June 2024, a total of 3 participants have consented and been randomized (n=1, exercise group; n=2, waitlist control) group. Trial completion is expected in July 2025.
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 on a prehabilitative exercise intervention designed to support patient prognosis. Clinical Trial: [https://clinicaltrials.gov/study/NCT05706766] identifier [NCT05706766]
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