BridgeMD
New treatment option for Multiple Myeloma
Official title Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
ClinicalTrials.gov ID: NCT05706766
What this study is testing
- What it's testing
- 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)
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Over 18 years old.
- All patients will have a diagnosis of multiple myeloma, referral to DFCI transplant team, and assigned to the autologous transplantation waiting list...
- Planning to receive autologous stem cell transplant after 8 weeks with or without concurrent neoadjuvant treatments at Dana-Farber Cancer Institute.
- Medical clearance to perform moderate-vigorous intensity aerobic and resistance exercise intervention and fitness testing by their treating physician...
- Speak English.
You likely can't join if
- History of unstable angina, abnormal resting ECG and/or unstable angina or a heart attack in the previous month to allow safe completion of the...
- Patients with known spinal instability, spinal cord compression or neurological deficits or contraindications that preclude exercise.
- Those who have had recent (within six weeks) spinal surgery or other intervention surgery for pathological fractures.
- Those deemed unsuitable to partake by the transplant or study team.
- Patients at high-risk of impending pathologic fracture of a weight-bearing bone (including spine, hip/femur and humerus) as determined by physician.
- Unable or unwilling to undertake an exercise program on a regular basis.
See the full eligibility criteria
- Over 18 years old.
- All patients will have a diagnosis of multiple myeloma, referral to DFCI transplant team, and assigned to the autologous transplantation waiting list for a first transplant.
- Planning to receive autologous stem cell transplant after 8 weeks with or without concurrent neoadjuvant treatments at Dana-Farber Cancer Institute.
- Medical clearance to perform moderate-vigorous intensity aerobic and resistance exercise intervention and fitness testing by their treating physician or a certified clinical exercise physiologist.
- Speak English.
- Currently participate in less than or equal to 60 minutes of structured moderate-vigorous intensity exercise/week.
- Willing to travel to Dana-Farber Cancer Institute for necessary data collection.
- Ability to understand and the willingness to sign a written informed consent document.
- The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception (hormonal or barrier method of...
- History of unstable angina, abnormal resting ECG and/or unstable angina or a heart attack in the previous month to allow safe completion of the cardiopulmonary exercise test (CPET) or VO2peak test.
- Patients with known spinal instability, spinal cord compression or neurological deficits or contraindications that preclude exercise.
- Those who have had recent (within six weeks) spinal surgery or other intervention surgery for pathological fractures.
- Those deemed unsuitable to partake by the transplant or study team.
- Patients at high-risk of impending pathologic fracture of a weight-bearing bone (including spine, hip/femur and humerus) as determined by physician.
- Unable or unwilling to undertake an exercise program on a regular basis.
- Pre-existing musculoskeletal or cardiorespiratory disease, or metabolic diseases that could exacerbate with exercise, in addition to other conditions deemed unsafe by physician.
- Patients with other active malignancies requiring active therapy.
- Participate in more than 60 minutes of structured moderate to vigorous intensity exercise/week.
- Unable to travel to Dana-Farber Cancer Institute for necessary data collection.
- people, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.