Inspiratory Muscle Training in Obese Breast Cancer Survivors (IMOCS)

The Ohio State University

Status: Enrolling

Conditions: Breast Cancer; Cancer Survivors; Obesity

Treatments: Behavioral: Inspiratory muscle training; Behavioral: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT05193149

OSU-22220

Details and patient eligibility

About

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.

Full 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).

Enrollment: 78 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

78 participants in 2 patient groups

4 wk IMT + 12 wk exercise

Experimental group

Description:

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

Treatment:

Behavioral: Exercise training

Behavioral: Inspiratory muscle training

4 wk SHAM + 12 wk exercise

Sham Comparator group

Description:

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

Treatment:

Behavioral: Exercise training