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A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant

CAREFit-BMT Program to Improve Cardiac Reserve in High-Risk Acute Myeloid Leukemia Patients Preparing to Undergo Allogeneic Hematopoietic Stem Cell Transplantation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks, 12 months
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "OUTLINE: Patients undergo at-home moderate-intensity aerobic exercises over 30 minutes, 5 days per week, as well as strength training over 15-30 minutes, 3 days per week for up to 12 weeks in the absence of unacceptable toxicity."
  • "Patients also undergo blood sample collection throughout the study."
  • "After completion of the study intervention, patients are followed for 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether CAREFit-BMT, a home exercise program, can improve heart function before a stem cell transplant. It is for adults newly diagnosed with acute myeloid leukemia (AML), a blood cancer, who are at high risk for transplant complications. The program includes exercises that raise your heart rate and build strength.

This clinical trial studies how well a home-based exercise intervention called Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT) works in improving heart function among patients with high risk acute myeloid leukemia (AML) undergoing stem cell transplant. Older adults and those with other medical conditions are at a higher risk for complications in the heart and blood vessels (cardiovascular). Older age at transplantation has been associated with nearly all cardiovascular complications occurring after stem cell transplant. This is likely explained by the structural and functional changes that occur in aging hearts as well as the larger burden of cardiovascular risk factors such as diabetes, high blood pressure, and obesity. CAREFit-BMT is a "prehabilitation" program, or exercise initiated prior to intensive therapy, that consists of aerobic exercises and strength training. CAREFit-BMT may be able to increase the likelihood of safe and successful transition to stem cell transplant in patients with high risk AML.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Able to understand the study and willing to sign a consent form.
  • Newly diagnosed with AML at Fred Hutch.
  • Meet at least one high-risk rule: age 65 or older; HCT-CI score of 3 or higher if age 20 or older; or CARE-BMT score of 5 or higher. These scores measure health risks, and study staff will check them before enrollment.
  • Able to do light to moderate exercise, as checked by study staff.
  • Have access to a smartphone.
  • Able to read and write in English.

Who can't join

  • Bone, joint, nerve, or other problems that make walking or following the study plan unsafe. Staff will consider past falls and recent problems.
  • AML that has come back, or another invasive cancer (cancer that grows into nearby tissue).
  • Severe anemia, or too few healthy red blood cells: hemoglobin below 7 gm/dl.
  • A history of severe aortic stenosis, a very narrowed heart valve.
  • Class IV heart failure, the most severe class of heart failure.
  • Severe pain with basic movement.
  • Pregnant.
  • Unable to give consent.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 18 years or older * Ability to understand and willingness to sign a written informed consent document * New diagnosis of acute myeloid leukemia at Fred Hutch * High-risk patients as defined by one, or more, of the following criteria: * Age 65 years or older and/or * Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3 (for patients 20 years old or older) and/or * CARE-BMT score ≥ 5 * Note: HCT-CI and CARE-BMT scores will be measured at pre-screening by study staff * Able to exercise at low to moderate intensity, as evaluated by study staff * Access to a mobile smart phone * Able to read and write in English Exclusion Criteria: * Orthopedic, neurologic, or other problems that prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility * Recurrence of AML or diagnosis of other invasive cancer * Severe anemia (hemoglobin \< 7 gm/dl) * History of severe aortic stenosis * New York Heart Association (NYHA) class IV heart failure * Severe pain with basic movement * Pregnant persons * Unable to give consent

Study sites (1)

WA