This is a randomized clinical trial that studies symptom-adapted physical activity intervention in minimizing physical function decline in older patients with acute myeloid leukemia (AML) undergoing chemotherapy. Physical activity may help decrease functional impairment and improve the quality of life in patients with AML 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
70
Ancillary studies
Receive lifestyle-related counseling
Undergo physical activity intervention
Receive educational materials
Undergo usual care
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Feasibility, in terms of participation rates and barriers to recruitment and retention
Number of exercise sessions completed, dropout rates, completion rates of the physical function measures, and completion rates of questionnaires will be recorded. Adherence will be defined as completion of at least 60% of the offered sessions.
Time frame: Approximately 4 weeks
Magnitude and trajectory of changes in objective physical function
Characterized using mixed model analysis of variance (ANOVA) with an appropriate error structure to account for the correlated nature of the data.
Time frame: Approximately 4 weeks
Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength
Time frame: Approximately 4 weeks
Self-reported quality of life
Time frame: Approximately 24 weeks
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