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
• current smokers
• metastatic breast cancer
• ongoing or active infection with recent antibiotics or steroids
• 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