About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent prior to any study-related procedures
Women newly diagnosed (Stage I-III) breast cancer.
Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
Disqualifiers
Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease
Patients with other active malignancies are ineligible for this study.
Patients with metastatic disease
Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
Trial design
Parallel
Treatments tested in this trial
High-Intensity Intervals Training
Behavioral16 week exercise program with stationary bike.
Attention Control
Other intervention16 week stretching program.
Treatment groups
Trial outcomes
Primary outcomes
Executive Function and Attention
Assess executive functioning of High-Intensity Interval Training (HIIT) to attention controls participants using the Flanker test.
Executive Function-Global Cognition
Assess global cognition of High-Intensity Interval Training (HIIT) to attention controls participants using the Montreal Cognitive assessment.
Executive Function-Working Memory
Assess working memory of High-Intensity Interval Training (HIIT) to attention controls participants using the Digital Symbol and Trials test
Executive Function-Episodic Memory
Assess episodic memory of High-Intensity Interval Training (HIIT) to attention controls participants using the complex figure diagram copy test
Secondary outcomes
Cardio Fitness-maximal aerobic capacity
Cardiorespiratory fitness will be measured through a VO2 max test
Cardio Fitness-maximal power output
Cardiorespiratory fitness will be measured through a VO2 max test
Sponsors and contacts
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Dana-Farber Cancer Institute
Lead sponsor
American Institute for Cancer Research
Collaborator