Actively Recruiting
Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer Survivors
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-01-07
78
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of inspiratory muscle training (IMT) in improving exercise tolerance among obese breast cancer survivors who have completed active treatment for stage 0 to III breast cancer. The study involves individuals with obesity, defined by a body mass index (BMI) of 30 to 50 kg/m2, and focuses on those who are sedentary and have some exercise intolerance. This randomized controlled trial aims to provide insights into how IMT combined with exercise may benefit this population. Participants are randomly assigned to one of two groups: one group receives 4 weeks of inspiratory muscle training using a pressure threshold device at up to 70% of maximal inspiratory pressure, performed three times per week with three sets of 15 repetitions. This is followed by 12 weeks of aerobic exercise training including activities like cycling, walking, and elliptical sessions three times per week for up to 50 minutes per session at moderate intensity. The second group receives 4 weeks of sham training at 10% of maximal inspiratory pressure with the same exercise program starting in week 5. The study is double-blinded to compare the effects of IMT plus exercise versus sham training plus exercise. During the 16-week study, participants undergo assessments at baseline, after 4 weeks, and at 16 weeks to measure changes in exercise tolerance, inspiratory muscle strength and endurance, exercise capacity, dyspnea, and fatigue. The study includes supervised exercise sessions and uses a pressure threshold device for training. Researchers monitor safety and adherence closely. The total participation involves 4 weeks of initial training followed by 12 weeks of aerobic exercise, with ongoing evaluation of physical function and symptoms related to breathing and fatigue.
CONDITIONS
Brief Title
Inspiratory Muscle Training in Obese Breast Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed active treatment for stage 0-III breast cancer within 6 months to 5 years before enrollment
- Obese with a body mass index (BMI) between 30 and 50 kg/m2
- On adjuvant endocrine therapy allowed
- Sedentary, participating in less than 90 minutes of moderate intensity activity per week
- Have at least one limitation in activity on the 10-question RAND-36 Physical Function Subscale indicating exercise intolerance
You will not qualify if you...
- Functional limitations making independent exercise unsafe
- Metastatic breast cancer
- Ongoing or active infection with recent use of antibiotics or steroids
- Bilateral axillary lymph node dissection of more than 5 lymph nodes on each side
- Heart disease that precludes exercise, including congestive heart failure, unstable angina, or cardiac arrhythmia
- Psychiatric illness or social situations limiting compliance
- Orthopedic, neuromuscular disorders, or arthritis preventing exercise
- Unwilling or unable to follow study protocol
- Pregnant or nursing
- Any condition deemed unsuitable by the investigator
- Provokable ECG changes suggesting heart disease or dangerous arrhythmias during exercise testing
- Non-English speaking
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants undergo 4 weeks of inspiratory muscle training or sham training to improve respiratory muscle strength.
3 visits per week (in-person)
Duration - 12 weeks
Participants engage in 12 weeks of supervised aerobic exercise including cycling, walking, and elliptical activities at moderate intensity.
3 visits per week (in-person)
Trial Site Locations
Total: 1 location
1
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
D
Dharini M Bhammar, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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