A pilot phase II RCT of a home-based exercise intervention for survivors of AML

Abstract

Background: Fatigue is the most common and disabling symptom affecting quality of life (QOL) and daily function in patients who have completed treatment for acute myeloid leukemia (AML). Although trials in patients with various solid tumors have reported improved fatigue and QOL following exercise interventions, there have been no studies in AML patients post treatment.

Methods: Forty patients aged ≥ 40 years who had completed treatment for AML were enrolled in a 12-week randomized phase II exercise intervention to determine feasibility (recruitment, retention, and adherence), efficacy, and safety of the intervention. Patients assigned to the exercise group received an individualized, moderate-intensity, 12-week home-based exercise program with weekly telephone support from a certified exercise physiologist. QOL, fatigue, and fitness outcomes were measured at baseline, 6 weeks, and 12 weeks. Between-group differences in 12-week change scores were calculated using linear regression adjusting for age and baseline function.

Results: Recruitment and retention rates were 38% and 91%, respectively. Adherence was low at 28%. Analyses did not suggest statistically significant or clinically important benefits in QOL, fatigue, or physical fitness with the intervention. The level of adherence did not appear to impact outcomes. There were no adverse events.

Conclusion: A home-based exercise program for post-treatment AML patients age 40 years or older can be safely delivered with reasonable recruitment and high retention. However, feasibility was hampered by low adherence. Further research and program modification are needed to better understand and overcome barriers to exercise delivery and adherence in AML survivors.