This clinical trial is to find out the possible benefits and side effects of aerobic exercise therapy in treating patients with cancer hospitalized for COVID-19. Researchers have found that aerobic exercise is safe and can improve health in cancer patients after they receive treatment for their cancer. This study will provide information about how safe and helpful exercise is for cancer patients recovering from COVID-19.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04824443.
PRIMARY OBJECTIVE:
I. To evaluate safety and tolerability of 30 weeks of aerobic exercise therapy (AT).
SECONDARY OBJECTIVES:
I. To evaluate change in exercise tolerance (estimated oxygen consumption [VO2]peak; ml O2.kg^-1.min^-1).
II. To evaluate change in digital physiological data including body weight, blood pressure, sleep, general mobility, resting heart rate, and oxygen saturation.
III. To evaluate change in patient-reported outcomes (PRO) (e.g., quality of life, fatigue).
EXPLORATORY OBJECTIVES:
I. To explore changes in physiological factors as assessed by pulmonary function (i.e., forced expiratory volume in one second).
II. To explore changes in biological factors as assessed by:
IIa. Immune phenotypes.
IIb. Microbiome phenotypes.
III. To explore feasibility of acquiring tele-guided resting cardiac function.
IV. To explore AT pharmacodynamics as evaluated by temporal changes in physiological, PRO, and biological factors.
OUTLINE:
Patients participate in aerobic exercise therapy sessions consisting of treadmill walking over 20-75 minutes 6 days a week for 30 weeks.
After completion of study, patients are followed up withing 3 weeks.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJessica Scott