The goal of this research study is to investigate whether a virtual, home-based, prehabilitation aerobic and resistance exercise (PARE) training program implemented 8 weeks prior to receiving autologous stem cell transplant (ASCT) for multiple myeloma participants will improve muscular strength, physical capacity, patient reported outcomes, and cardiometabolic health outcomes. The names of the study interventions involved in this study are: * Prehabilitative aerobic and resistance exercise (PARE) (virtually supervised 8-week aerobic and resistance exercise program) * Waitlist control (8-week normal activity behavior)
This is a single-center, prospective, parallel-group, randomized controlled study that will enroll patients diagnosed with multiple myeloma planning to receive autologous stem cell transplant (ASCT). Participants will be randomized into one of the intervention groups: Exercise Group (PARE) versus Waitlist Control Group. Randomization means that participants are placed into one of the treatment groups by chance. The research study procedures include screening for eligibility and study treatment including evaluations of muscle strength, cardiorespiratory fitness, physical fitness assessments, body composition including DEXA scans, blood tests, and surveys at study entry and follow-up visits. Participation is expected to last about 4 months for the Exercise Group (PARE) and 9 months for the Waitlist Control Group. It is expected about 30 people with take part in this research study. Dana-Farber Cancer Institute is supporting this research study by providing funding through the Population Sciences Team Science Concept program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
Aerobic and resistance exercise program via Zoom platform.
Normal Activities.
Dana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGDifference in Muscular Strength
The primary analysis is a mean difference in percent change between the intervention (PARE) and the control (Waitlist) groups in lower leg muscle strength measured through leg press.
Time frame: Pre-transplant (Week 9, post-intervention), and post-transplant (Week 14-15, 30 Day Post-ASCT Follow-Up)
Difference in Physical Capacity
Physical capacity includes physical function and cardiorespiratory fitness which are measured through the Short Physical Performance Battery (SPPB) protocol and a maximal oxygen uptake (VO2 max) test, respectively. Differences in physical capacity across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.
Time frame: up to 9 months
Difference in Patient Reported Outcomes
Patient reported outcomes, including fatigue and quality of life, are assessed through validated questionnaires. Differences in patient reported outcomes across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.
Time frame: up to 9 months
Difference in Cardiometabolic Health Outcomes
Cardiometabolic health outcomes, including biomarkers of metabolic syndrome and body composition will be assessed through blood draws and dual-energy X-ray absorptiometry (DEXA), validated and safe measures. Differences in cardiometabolic health outcomes across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.
Time frame: up to 9 months
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