Breast Cancer Clinical Trial

Inspiratory Muscle Training in Obese Breast Cancer Survivors

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.

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Full Description

The proposed study has two parts:

Randomized controlled trial (RCT) where obese participants (N=133) are randomized to three arms: [i] IMT 4 wks + IMT&Exercise 12 wks, [ii] IMT 4 wks + Exercise 12 wks, [iii] SHAM 4 wks + Exercise 12 wks).
Cross-sectional trial where nonobese participants (N=50) will be recruited to assess differences in exercise tolerance and its underlying physiological mechanisms between obese and nonobese participants.

Only the RCT part involves random assignment of participants and the clinical trial.

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Eligibility Criteria

Inclusion Criteria:

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 & nonobese as defined as BMI 18.5 to 24.9 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 Criteria:

functional limitations that make independent exercise unsafe
current smokers
metastatic breast cancer
ongoing or active infection with recent antibiotics or steroids
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

Study is for people with:

Breast Cancer

Estimated Enrollment:

183

Study ID:

NCT05193149

Recruitment Status:

Not yet recruiting

Sponsor:

Ohio State University

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There is 1 Location for this study

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The Ohio State University
Columbus Ohio, 43210, United States More Info
Dharini M Bhammar, PhD
Contact
614-366-9467
[email protected]
Dharini M Bhammar, PhD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

183

Study ID:

NCT05193149

Recruitment Status:

Not yet recruiting

Sponsor:


Ohio State University

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