This clinical trial tests the effect of prehabilitation aerobic and resistance exercise (PARE) on muscular strength, physical capacity, physical function and patient reported outcomes in patients with multiple myeloma prior to autologous stem cell transplantation (ASCT). Multiple myeloma is the second most common hematological cancer and 98% of patients that are eligible undergo ASCT in which the patient donates their own stem cells, with the goal of remission or to increase life span. ASCT can have a significant impact on patients overall physical function and quality of life creating an increased risk of worsened overall survival. Poor muscle mass has been shown to be related to increased postoperative complications. Physical activity that increases the heart rate and the body's use of oxygen (aerobic exercise) can improve heart (cardiovascular) and lung function. Resistance exercise, which is the act of moving the body against some form of resistance, or weight, can help build muscle mass and strength. Participating in PARE prior to ASCT may improve muscle strength, physical function, post-transplant outcomes and quality of life in patients with multiple myeloma.
Additional locations may be listed on ClinicalTrials.gov for NCT05706766.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Christina Dieli-Conwright
Phone: 617-582-8321
Brigham and Women's HospitalStatus: Active
Contact: Christina Dieli-Conwright
Phone: 617-582-8321
PRIMARY OBJECTIVE:
I. To determine the effects of an 8-week, virtually supervised, aerobic and resistance exercise intervention on muscle strength.
SECONDARY OBJECTIVE:
I. To determine the effects of an 8-week, virtually-supervised, aerobic and resistance exercise intervention on physical capacity (physical function and cardiorespiratory fitness) and patient reported outcomes (fatigue and quality of life), cardiometabolic health outcomes (biomarkers and body composition).
TERTIARY OBJECTIVE:
I. To determine the effects of an 8-week, virtually-supervised, aerobic and resistance exercise intervention on post-transplant clinical outcomes include Hematopoietic Cell Transplantation-Comorbidity Index, length of hospital stay, readmission rates, and treatment-related adverse events.
EXPLORATORY OBJECTIVE:
I. To determine the effects of an 8-week, virtually-supervised, aerobic and resistance exercise intervention completed post-ASCT on muscle strength, physical capacity, patient reported outcomes, and cardiometabolic health outcomes.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in virtually-supervised PARE sessions via Zoom for up to 12 weeks prior to ASCT on study. Patients also undergo blood sample collection and dual-energy X-ray absorptiometry (DEXA) scan at baseline, post-intervention, during follow-up, and post-elected exercise.
ARM II: Patients continue usual activity on study. Patients also undergo blood sample collection and DEXA scan at baseline, post-intervention, during follow-up, and post-elected exercise. Patients offered the option to participate in the PARE program at study completion.
After completion of study intervention, patients/participants are followed up at 30 days.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorChristina Dieli-Conwright