Improving exercise tolerance in obese breast cancer survivors through inspiratory muscle training
Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer
This study is testing if a special breathing exercise can help obese breast cancer survivors improve their ability to exercise and feel better overall.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05193149 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of inspiratory muscle training (IMT) combined with exercise in enhancing exercise tolerance among obese breast cancer survivors. Participants, who are randomized into two groups, will either receive IMT for four weeks followed by 12 weeks of exercise or a sham treatment followed by the same exercise regimen. The study aims to enroll 133 obese individuals who have completed their cancer treatment within the last five years and experience limitations in physical activity. By assessing the outcomes, the trial seeks to determine if IMT can significantly improve physical function and quality of life for this population.
Who should consider this trial
Good fit: Ideal candidates are obese breast cancer survivors who have completed active treatment within the last 6 months to 5 years and experience limitations in physical activity.
Not a fit: Patients with metastatic breast cancer or significant functional limitations that prevent safe independent exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance physical fitness and overall well-being for obese breast cancer survivors.
How similar studies have performed: While similar approaches have been explored, this specific combination of inspiratory muscle training and exercise in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 * 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 * 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 this trial is running
Columbus, Ohio
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Dharini M Bhammar, PhD — Ohio State University
- Study coordinator: Dharini M Bhammar, PhD
- Email: dharini.bhammar@osumc.edu
- Phone: 6143669467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.