Inspiratory Muscle Training in Obese Breast Cancer Survivors

Not Applicable

Recruiting

• Conditions: Obesity; Cancer Survivors; Breast Cancer
• Interventions: Behavioral: Inspiratory muscle training; Behavioral: Exercise training

• Registration Number: NCT05193149
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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).

Study Timeline

• Study First Submitted: 2021-12-31
• Study First Submitted QC: 2021-12-31
• Study First Posted: 2022-01-14
• Study Start: 2023-11-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-27
• Last Update Posted: 2024-12-31
• Primary Completion: 2028-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 wk IMT + 12 wk exercise	Inspiratory muscle training	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
4 wk IMT + 12 wk exercise	Exercise training	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
4 wk SHAM + 12 wk exercise	Exercise training	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

Primary Outcome Measures

Name	Time	Method
Change in exercise tolerance	Baseline to 16 weeks	Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.

Secondary Outcome Measures

Name	Time	Method
Change in inspiratory muscle endurance	Baseline to 16 weeks	Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min
Change in fatigue	Baseline to 16 weeks	Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52
Change in exercise capacity	Baseline to 16 weeks	Continuous variable, peak oxygen uptake. Units: L/min
Change in dyspnea	Baseline to 16 weeks	Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4
Change in inspiratory muscle strength	Baseline to 16 weeks	Continuous variable, Maximal inspiratory pressure. Units: cm H20

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States