Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial
Summary
The purpose of this study is to examine the feasibility and effects of 12-week exercise training at different intensities among individuals with advanced lung cancer receiving immune checkpoint inhibitors. The names of the study interventions involved in this study are:
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: * High-intensity interval training (HIIT) * Moderate-intensity continuous training (MICT) * Usual care (UC) The HIIT and the MICT groups will receive virtually supervised home-based exercise training three sessions per week for 12 weeks. The UC group will be asked not to change their baseline exercise behavior and will be offered to receive one of the exercise programs at the end of the initial 12 weeks.
Arms & interventions
- BehavioralHigh-Intensity Interval Training (HIIT)
Home-based, virtually supervised, aerobic exercise intervention at a high intensity in an interval fashion.
- BehavioralModerate-Intensity Continuous Training (MICT)
Home-based, virtually supervised, aerobic exercise intervention at a moderate intensity in a continuous fashion.
Outcome measures
Primary
Proportion of Participants completing the exercise intervention sessions
The primary outcome is feasibility and will be assessed by the proportion of enrolled participants completing the exercise intervention sessions with \>/=70% completion considered feasible.
Time frame: Up to 14 weeks
Secondary
Neutrophil-lymphocyte ratio (NLR)
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Cardiopulmonary Fitness
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Muscular Strength
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Short Physical Performance Battery
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Health-related quality of life
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Lung-cancer related quality of life
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Immunotherapy Symptoms
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Anxiety and Depression
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Sleep Quality
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Eligibility criteria
Study locations (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215