Symptom-Adapted Physical Activity Intervention in Minimizing Physical Function Decline in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of conducting a symptom-adapted, randomized behavioral
intervention designed to improve physical function in older adults receiving chemotherapy for
AML.

II. To estimate the effect size of the physical activity intervention on change in an
objective measure of physical function, SPPB (short physical performance battery).

SECONDARY OBJECTIVES:

I. To estimate the effects of the physical activity intervention on self-reported physical
function, health-related quality of life, and symptoms (depression, distress, fatigue).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients participate in an orientation session introducing the exercise program and
protocol, reviewing fundamental principles, and demonstrating each activity. Patients also
receive educational materials to facilitate orientation and adherence. Patients are offered
20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a
week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once
weekly.

ARM II: Patients undergo usual care for 4 weeks.

After completion of study treatment, patients are followed up every two weeks for two months
and then monthly until week 24.

Inclusion Criteria:

- Diagnosis of AML with pathologic confirmation by World Health Organization (WHO)
criteria

- Planned induction chemotherapy

- Absence of active medical problems that preclude participation in exercise (including,
but not limited to: bleeding, acute thrombosis, ischemia, hemodynamic instability,
uncontrolled pain)

- Patient must be ambulatory or able to walk with a cane

- Patients must have limited cognitive deficits (< 3 incorrect responses on the Pfeiffer
Mental Status Scale)

- Adequate English skills to understand and complete questionnaires

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Presence of active medical conditions precluding participation to exercise (e.g.,
ischemia, bleeding, thrombosis, uncontrolled pain, hemodynamic instability)

- Inability to ambulate