Status:
RECRUITING
Inspiratory Muscle Training in Obese Breast Cancer Survivors
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Cancer Survivors
Obesity
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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.
Detailed Description
Randomized controlled trial (RCT) where obese participants (N=133) are randomized to 2 arms: \[i\] IMT 4 wks + Exercise 12 wks, \[ii\] SHAM 4 wks + Exercise 12 wks).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05193149
Start Date
November 13 2023
End Date
June 30 2026
Last Update
January 7 2026
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210