Inspiratory Muscle Training in Obese Breast Cancer Survivors
NCT ID: NCT05193149
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
78 participants
INTERVENTIONAL
2023-11-13
2029-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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4 wk IMT + 12 wk exercise
4 weeks of IMT, 3/week, 3 sets of 15 repetitions, intensity up to 70% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity
Inspiratory muscle training
Training of respiratory muscles
Exercise training
Supervised aerobic exercise intervention
4 wk SHAM + 12 wk exercise
4 weeks of SHAM training, 3/week, 3 sets of 15 repetitions, intensity up of 10% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity
Exercise training
Supervised aerobic exercise intervention
Interventions
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Inspiratory muscle training
Training of respiratory muscles
Exercise training
Supervised aerobic exercise intervention
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Dharini Bhammar
Assistant Professor
Principal Investigators
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Dharini M Bhammar, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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The Ohio State University
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Dharini M Bhammar, PhD
Role: primary
Related Links
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The Jamesline
Other Identifiers
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OSU-22220
Identifier Type: -
Identifier Source: org_study_id