Feasibility of a Symptom-Adapted Physical Activity Intervention during Induction Chemotherapy for Older Adults with Acute Myeloid Leukemia (AML)
Authors: Klepin Heidi D. , Tooze Janet , Pardee Timothy , Ellis Leslie Renee , Berenzon Dmitriy , Howard Dianna , Demark-Wahnefried Wendy , Mihalko Shannon , Rejeski William Jack , Powell Bayard L. , Kritchevsky Stephen 
Published: October 2019

Abstract
Background: Poor treatment tolerance contributes to suboptimal outcomes for many older adults with acute myeloid leukemia (AML). Treatment-associated physical deconditioning during induction may limit therapeutic options and impair quality of life. Interventions to enhance physical function during therapy may improve treatment tolerance and benefit.
Objective: To test the feasibility of conducting a symptom-adapted inpatient physical activity (PA) intervention among older adults receiving intensive induction chemotherapy for AML.
Methods: A single institution randomized controlled pilot study (N=70) was conducted from October 2012-July 2015. Eligibility included age ≥60 years, newly diagnosed AML, and receipt of induction chemotherapy. Exclusion criteria included medical contraindication to PA at the time of enrollment, cognitive impairment, and/or receipt of low intensity therapy. Participants randomized to the intervention were offered a PA session five days per week tailored daily to symptoms and health status during the induction hospitalization. Session options included: 1) Standard (ward-based), walking + balance training + resistance exercises; 2) Intermediate (room-based), upper-body ergometer + balance training + resistance exercises; and 3) Low-intensity (bed-based), upper-body ergometer + resistance exercises. Counseling sessions to establish PA goals and trouble-shoot barriers were conducted weekly during hospitalization. Phone counseling to reinforce PA goals continued monthly post-hospitalization during follow-up (up to 6 months). The control arm received usual care. Assessment of physical function (self-report and objective), mood, symptoms, and quality of life was done at baseline, 3 months and 6 months with weekly physical function testing while hospitalized. The primary outcome was feasibility defined as recruitment (≥60%), adherence (>75%, average 3 sessions/week), and retention (85% follow-up for eligible participants).
Results: There were 97 eligible patients of which 70 enrolled (recruitment rate 72%). The study sample was 70% male, mean age was 72.1 years (Standard Deviation [SD] 6.3), mean Hematopoietic Cell Transplantation Comorbidity index score was 2.0 (SD 1.8), mean hemoglobin 9.3 (SD 1.6), mean white cell count 17 (SD 33.7), and 93% had adequate ECOG performance status (0-2). The majority had intermediate (61%) or poor (33%) risk cytogenetics. Most common induction regimens included anthracycline+cytarabine (80%) and clofarabine (15.7%). A total of 732 PA sessions were offered during the course of the study. Patients were deemed medically ineligible to participate in 13% of these sessions. Of eligible sessions, the participation rate was 80%. Of weeks with at least one eligible day, the average number of weekly sessions conducted per participant was 3.0 (SD 1.6). Overall mean number of sessions/participant was 14.5 (SD 9.4). Among the 35 participants randomized to the intervention 74% completed a program evaluation. Most reported that they liked the program (88%), found it helpful (88%) and planned to continue physical activity post discharge (69%). The activities rated to be most helpful were: combination of balance + resistance exercises + walking (31%), resistance exercises alone (23%) and balance exercises alone (15%). Retention was 96% among evaluable participants (survived at least to the 3 month follow-up assessment, N=53).
Conclusions: Delivery of a symptom-adapted inpatient PA intervention to older adults receiving intensive induction chemotherapy for AML is feasible and well received by participants. Next steps include estimation of the effect size of the intervention on physical function, symptoms, and quality of life.

Disclosures
Pardee: Celgene: Speakers Bureau; Novartis: Speakers Bureau.