Breast Cancer, Cancer Survivors, Obesity
Conditions
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).
Interventions
BEHAVIORALInspiratory muscle training
Training of respiratory muscles
BEHAVIORALExercise training
Supervised aerobic exercise intervention
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Staff completing outcomes testing and study participants will be blinded to treatment assignment (IMT/SHAM). The IMT/SHAM devices are the same with ability to alter resistance; however, upon use at the lower intensity, the participant may be able to tell whether the device has resistance.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in exercise tolerance | Baseline to 4 weeks | Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in inspiratory muscle strength | Baseline to 4 weeks | Continuous variable, Maximal inspiratory pressure. Units: cm H20 |
| Change in inspiratory muscle endurance | Baseline to 4 weeks | Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min |
| Change in exercise capacity | Baseline to 4 weeks | Continuous variable, peak oxygen uptake. Units: L/min |
| Change in dyspnea | Baseline to 4 weeks | Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4 |
| Change in fatigue | Baseline to 4 weeks | Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDharini M Bhammar, PhD
Ohio State University
Outcome results
None listed