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Brief Title: Feasibility and Preliminary Efficacy of Exercise During Immunotherapy in Patients With Lung Cancer: The INHALE Trial
Official Title: Feasibility and Preliminary Efficacy of Exercise During Immunotherapy in Patients With Lung Cancer: The INHALE Trial
Study ID: NCT06026111
Brief Summary: The purpose of this study is to determine whether a 12-week, home-based, virtually supervised exercise intervention is feasible and improves various health outcomes among individuals with advanced lung cancer receiving immunotherapy. The names of the study interventions involved in this study are: * High-intensity interval training (HIIT) (Home-based, virtually supervised, high intensity training in an interval fashion) * Moderate-intensity continuous training (MICT) (Home-based, virtually supervised, moderate intensity in a continuous fashion) * Usual care (UC)
Detailed Description: This single-center, two-armed, pilot randomized controlled research study will assess feasibility and compare immune activities, cardiorespiratory fitness, physical function, and immunotherapy-related adverse events, and patient-reported outcomes between three groups - high-intensity exercise, moderate-intensity exercise, and usual care. Participants in this study will be randomly assigned to one of three groups: Group A High-intensity interval training (HIIT), Group B Moderate-intensity continuous training (MICT), or Group C Usual Care (UC). The HIIT and the MICT groups will receive virtually (Zoom) supervised home-based exercise training three sessions per week for 12 weeks. Randomization means that a participant is placed into a study group by chance. The research study procedures include screening for eligibility and study treatment including extensive evaluations of fitness and physical health, blood tests, and questionnaires/surveys. Participation in this research study is expected to last for up to 12 weeks. It is expected that about 30 people will take part in this research study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Name: Christina Dieli-Conwright, MPH, PhD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR