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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 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.

Locations
United States
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Christina Dieli-Conwright, PhD, MPH
christinam_dieli-conwright@dfci.harvard.edu
617-582-8321
Time Frame
Start Date: 2023-06-29
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 30
Treatments
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.
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.
Sponsors
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov