Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (The CLARITY Trial)
Summary
The purpose of this research is to determine whether a 16-week high intensity interval training (HIIT) exercise program will improve brain health among women undergoing chemotherapy and also improve cardiovascular (heart) function. The names of the study interventions involved in this study are/is: * High-Intensity Interval Training (HIIT)
Detailed description
This research study is a randomized controlled pilot trial that will compare an exercise group to a control group on brain health, cardiac fitness and overall quality of life in breast cancer patients starting chemotherapy either before (pre-operative or neoadjuvant) or after surgery (post-operative or adjuvant) This research study is a Pilot Study, which is the first-time investigators are examining this intervention in this setting. The study is trying to determine whether participating in a specific exercise program can improve brain and heart function, as there is some evidence that there can be cognitive changes after chemotherapy among some patients with breast cancer. This study intends to evaluate whether HIIT can improve cognitive function as well as cardio-respiratory fitness, among patients undergoing chemotherapy for breast cancer. Participants will be randomly assigned to one of two groups: * Group A: High Intensity Interval Training (HIIT) for 16 weeks * Group B: Attention Control for 16 weeks home-based stretching; the HIIT intervention will be available after the study ends The research study procedures include screening for eligibility and study treatment including extensive evaluations of your fitness and brain health, including MRI, blood tests, bone scans, fitness and strength assessments, and surveys at study entry and follow up visits. Participants will receive study treatment for 4 months and will be followed for 4 months. The total time for participation in this study will be about 8 months. It is expected that about 30 people will take part in this research study. The American Institute for Cancer Research is supporting this research by providing funding for the study.
Arms & interventions
- BehavioralHigh-Intensity Intervals Training
16 week exercise program with stationary bike.
- OtherAttention Control
16 week stretching program.
Outcome measures
Primary
Executive Function and Attention
Assess executive functioning of High-Intensity Interval Training (HIIT) to attention controls participants using the Flanker test.
Time frame: 16 weeks
Executive Function-Global Cognition
Assess global cognition of High-Intensity Interval Training (HIIT) to attention controls participants using the Montreal Cognitive assessment.
Time frame: 16 weeks
Executive Function-Working Memory
Assess working memory of High-Intensity Interval Training (HIIT) to attention controls participants using the Digital Symbol and Trials test
Time frame: 16 weeks
Executive Function-Episodic Memory
Assess episodic memory of High-Intensity Interval Training (HIIT) to attention controls participants using the complex figure diagram copy test
Time frame: 16 weeks
Executive Function-Semantic Fluency
Assess semantic fluency of High-Intensity Interval Training (HIIT) to attention controls participants using the category fluency test
Time frame: 16 weeks
Resting state connectivity and structural diffusion tensor imaging (DTI) connectivity
Assess resting state connectivity and DTI connectivity through functional magnetic resonance imaging (fMRI)
Time frame: 16 weeks
Secondary
Cardio Fitness-maximal aerobic capacity
Time frame: 16 weeks
Cardio Fitness-maximal power output
Time frame: 16 weeks
Eligibility criteria
Study locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115
References
- Wilson R, Kang DW, Tahbaz M, Norris M, Uno H, Ligibel J, Guenette J, Christopher C, Dieli-Conwright C. Improving Cognitive Function Through High-Intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 7;12:e39740. doi: 10.2196/39740.(PubMed)