Inspiratory Muscle Training in Obese Breast Cancer Survivors

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Cancer Survivors, Obesity, Breast Cancer

In brief

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.

Key facts

Study ID

NCT05193149

Run by

Ohio State University Comprehensive Cancer Center

People needed

77

Starts

2023-11-13

Expected to finish

2026-10-30

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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