Recruiting

Prehabilitation Exercise

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT05706766

Conditions

Multiple Myeloma

Stem Cell Transplant Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PARE

Waitlist Control Group

Study Details

Brief 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)

Conditions

Multiple Myeloma

Stem Cell Transplant Complications

Study ID

NCT05706766

Start date

Jun 29, 2023

Status verified date

Jan, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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 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.

Exclusion Criteria:

  • 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.
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

PARE

Aerobic and resistance exercise program via Zoom platform.

Waitlist Control Group

Normal Activities.

Primary outcome measure

  • Difference in Muscular Strength [ Time Frame: Pre-transplant (Week 9, post-intervention), and post-transplant (Week 14-15, 30 Day Post-ASCT Follow-Up) ]

Central Contacts and Locations

Central contacts

Christina Dieli-Conwright, PhD, MPH

617-582-8321christinam_dieli-conwright@dfci.harvard.edu

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christina Dieli-Conwright, PhD, MPH

617-632-3800ChristinaM_Dieli-Conwright@dfci.harvard.edu

Principal Investigator:

Christina Dieli-Conwright, PhD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christina Dieli-Conwright

christinam_dieli-conwright@dfci.harvard.edu

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-01-22.