RecruitingNot ApplicableNCT05193149

Inspiratory Muscle Training in Obese Breast Cancer Survivors

Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer

Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

78 participants

Start Date

Nov 13, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Cancer Survivors Obesity

Summary

The investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in improving exercise tolerance among stage 0-III obese breast cancer survivors.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

completed active treatment for a Stage 0-III breast cancer diagnosis within 6 months to 5 years of enrollment.
obese as defined by a body mass index (BMI) of 30 to 50 kg/m2
patients who are on adjuvant endocrine therapy will be allowed to participate.
sedentary (participating in less than 90 min of moderate intensity activity per week) and have at least one limitation in activity on the 10-question RAND-36 Physical Function Subscale to ensure some exercise intolerance

Exclusion Criteria12

functional limitations that make independent exercise unsafe
metastatic breast cancer
ongoing or active infection with recent antibiotics or steroids
Bilateral Axillary lymph node dissection (ALND) of \>5 lymph nodes on each side, which could increase risk of lymphadenopathy with repeated blood pressure measurements during exercise or if patient has been advised by their clinician to avoid repeated BP measures on both arms. Bilateral Sentinel Lymph Node Biopsy (SLNB) will be allowed.
heart disease precluding exercise (congestive heart failure, unstable angina pectoris, cardiac arrhythmia)
psychiatric illness/social situations that would limit compliance with study requirements
orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise
unwilling or unable to follow protocol requirements
pregnant or nursing
any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study
presence of provokable ECG changes suggestive of heart disease, or dangerous arrhythmias or exercise induced hypertension, etc. during the cardiopulmonary exercise test
non-English speaking