Clinical trial NCT05193149: Inspiratory Muscle Training in Obese Breast Cancer Survivors
Official title: Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Survivors
Obesity
Breast Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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

Primary outcomes:
measure: Change in exercise tolerance
timeFrame: Baseline to 4 weeks
measure: Change in exercise tolerance
timeFrame: Baseline to 16 weeks
Secondary outcomes:
measure: Change in inspiratory muscle strength
timeFrame: Baseline to 4 weeks
measure: Change in inspiratory muscle strength
timeFrame: Baseline to 16 weeks
measure: Change in inspiratory muscle endurance
timeFrame: Baseline to 4 weeks
measure: Change in inspiratory muscle endurance
timeFrame: Baseline to 16 weeks
measure: Change in exercise capacity
timeFrame: Baseline to 4 weeks
measure: Change in exercise capacity
timeFrame: Baseline to 16 weeks
measure: Change in dyspnea
timeFrame: Baseline to 4 weeks
measure: Change in dyspnea
timeFrame: Baseline to 16 weeks
measure: Change in fatigue
timeFrame: Baseline to 4 weeks
measure: Change in fatigue
timeFrame: Baseline to 16 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Dharini M Bhammar, PhD
role: PRINCIPAL_INVESTIGATOR
References: