Inspiratory Muscle Training in Obese Breast Cancer Survivors

Breast Cancer Clinical Trial

— IMOCS  

Official title:

Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05193149
• Other study ID #: OSU-22220
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: June 30, 2029

Study information

• Verified date: November 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: Dharini M Bhammar, PhD
• Phone: 6143669467
• Email: dharini.bhammar[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer Survivors
• Obesity

Intervention

Behavioral:
• Inspiratory muscle training
Training of respiratory muscles
• Exercise training
Supervised aerobic exercise intervention

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in exercise tolerance	Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.	Baseline to 4 weeks
Primary	Change in exercise tolerance	Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.	Baseline to 16 weeks
Secondary	Change in inspiratory muscle strength	Continuous variable, Maximal inspiratory pressure. Units: cm H20	Baseline to 4 weeks
Secondary	Change in inspiratory muscle strength	Continuous variable, Maximal inspiratory pressure. Units: cm H20	Baseline to 16 weeks
Secondary	Change in inspiratory muscle endurance	Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min	Baseline to 4 weeks
Secondary	Change in inspiratory muscle endurance	Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min	Baseline to 16 weeks
Secondary	Change in exercise capacity	Continuous variable, peak oxygen uptake. Units: L/min	Baseline to 4 weeks
Secondary	Change in exercise capacity	Continuous variable, peak oxygen uptake. Units: L/min	Baseline to 16 weeks
Secondary	Change in dyspnea	Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4	Baseline to 4 weeks
Secondary	Change in dyspnea	Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4	Baseline to 16 weeks
Secondary	Change in fatigue	Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52	Baseline to 4 weeks
Secondary	Change in fatigue	Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52	Baseline to 16 weeks

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