RECRUITING

Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

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Conditions

Multiple MyelomaStem Cell Transplant ComplicationsAutologous Stem Cell TransplantAerobic Exercise ProgramResistance Exercise Program

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation: The PROTECT Trial

Quick Facts

Study Start:2023-06-29
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05706766

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Over 18 years old.
  2. * 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.
  3. * Planning to receive autologous stem cell transplant after 8 weeks with or without concurrent neoadjuvant treatments at Dana-Farber Cancer Institute.
  4. * 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.
  5. * Speak English.
  6. * Currently participate in less than or equal to 60 minutes of structured moderate-vigorous intensity exercise/week.
  7. * Willing to travel to Dana-Farber Cancer Institute for necessary data collection.
  8. * Ability to understand and the willingness to sign a written informed consent document.
  9. * 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 birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
  1. * 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.
  2. * Patients with known spinal instability, spinal cord compression or neurological deficits or contraindications that preclude exercise.
  3. * Those who have had recent (within six weeks) spinal surgery or other intervention surgery for pathological fractures.
  4. * Those deemed unsuitable to partake by the transplant or study team.
  5. * Patients at high-risk of impending pathologic fracture of a weight-bearing bone (including spine, hip/femur and humerus) as determined by physician.
  6. * Unable or unwilling to undertake an exercise program on a regular basis.
  7. * Pre-existing musculoskeletal or cardiorespiratory disease, or metabolic diseases that could exacerbate with exercise, in addition to other conditions deemed unsafe by physician.
  8. * Patients with other active malignancies requiring active therapy.
  9. * Participate in more than 60 minutes of structured moderate to vigorous intensity exercise/week.
  10. * Unable to travel to Dana-Farber Cancer Institute for necessary data collection.
  11. * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Contacts and Locations

Study Contact

Christina Dieli-Conwright, PhD, MPH
CONTACT
617-582-8321
christinam_dieli-conwright@dfci.harvard.edu

Principal Investigator

Christina Dieli-Conwright, PhD, MPH
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Christina Dieli-Conwright, PhD, MPH, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-29
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2023-06-29
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • Multiple Myeloma
  • Autologous Stem Cell Transplant
  • Aerobic Exercise Program
  • Resistance Exercise Program

Additional Relevant MeSH Terms

  • Multiple Myeloma
  • Stem Cell Transplant Complications