Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness after Breast Cancer Treatment, The ACTIVATE Trial

PRIMARY OBJECTIVES:

I. Determine the feasibility of an individually-adaptive exercise intervention among breast cancer survivors with reduced cardiorespiratory fitness through examination of recruitment rate, enrollment rate, loss to follow-up, intervention attendance, relative dose intensity (ratio of total completed to total planned cumulative dose), and adherence (using accelerometers).

II. Examine the endpoint of safety; and explore the endpoints of cardiorespiratory fitness; functional capacity; physiologic changes; and patient reported outcomes (PRO) in the intervention versus (vs) control arms.

III. Examine the endpoint of safety; and explore the endpoints of cardiorespiratory fitness; functional capacity; physiologic changes; and patient reported outcomes (PRO) in the aerobic exercise (AE) vs resistance exercise (RE) vs AE+RE intervention arms.

OUTLINE: Patients are randomized to the interventional groups or control group.

INTERVENTION GROUPS: Patients are randomized to 1 of 2 interventional arms.

ARM I: Patients participate in aerobic exercise (AE) sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and resistance exercise (RE) sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.

ARM II: Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.

CONTROL GROUP: After 24 weeks, patients receive a digital copy of the 12-week AE sessions and 12-week RE sessions and an outline of sessions for 24 weeks.