Dana-Farber Cancer Institute
Christina Dieli-Conwright, PhD
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)
Multiple Myeloma
Stem Cell Transplant Complications
PARE
Waitlist Control Group
Not Applicable
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 |
Estimated Enrollment : | 30 participants |
Masking : | None (Open Label) |
Primary Purpose : | Supportive Care |
Official Title : | Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation: The PROTECT Trial |
Actual Study Start Date : | June 29, 2023 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | July 31, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Exercise Group (PARE) Participants will be randomly assigned to the Exercise Group (PARE) and will complete study procedures as outlined: 8 weeks of 3x weekly sessions of virtually supervised aerobic and resistance exercise performed at home using study-provided stationary bike, resistance equipment, heart-rate monitor, and a wi-fi enabled tablet. Clinic visits at week 1, week 10, and 30 days post Autologous Stem Cell Transplantation (ASCT). Questionnaires and surveys. |
Behavioral: PARE |
Active Comparator: Waitlist Control Group Participants will be randomly assigned to the Waitlist Control Group and will complete study procedures as outlined: 8 weeks of continuing with normal daily activities. Option to participate in PARE exercise program after study completion. 3 clinic visits with option of 5 visits. The two additional visits are for evaluation and testing for those who choose to participate in exercise program after study completion. |
Behavioral: Waitlist Control Group |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215