This clinical trial studies whether breathing exercises for the muscles that help with breathing air in, inspiratory muscle training (IMT), works to improve breathing muscle strength, shortness of breath, and physical activity levels in women who are receiving chemotherapy for early-stage breast cancer (BC). Cancer and/or treatments for BC can directly result in muscle wasting that involves breathing muscles, skeletal muscles or heart muscles. Pain, weakness, shortness of breath, and side effects of cancer treatment may lead to lower physical activity levels. IMT involves breathing exercises using a small hand-held device. The device makes it a little harder to breathe in, which may help strengthen breathing muscles. IMT may be an effective way to improve breathing muscle strength, shortness of breath, and physical activity levels in women who are receiving chemotherapy for early-stage BC.
PRIMARY OBJECTIVE: To investigate the effects of 8 weeks of IMT on inspiratory muscle strength, exertional dyspnea, and physical activity levels among women undergoing chemotherapy for BC. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients complete three sets of fifteen repetitions per session of low-intensity IMT over 15-20 minutes four days a week for 8 weeks. ARM 2: Patients complete three sets of fifteen repetitions per session of high-intensity IMT over 15-20 minutes four days a week for 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
58
Training of respiratory muscles
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITINGMaximum inspiratory pressure
Measure of the strength of the inspiratory muscles. Units: cm H20
Time frame: Baseline to 8 weeks
Physical activity levels
Number of steps/day averaged weekly.
Time frame: Baseline to 8 weeks
Modified Medical Research Council Dyspnea scale rating
Patients will indicate the extent to which their dyspnea affects mobility using a one question 1-5 scale; higher scores indicate greater respiratory disability.
Time frame: Baseline to 8 weeks
Dyspnea 12 score
Questionnaire consists of 12 descriptor items such as "I feel short of breath" and "my breathing is uncomfortable" with each item rated on a scale of none (0), mild (1), moderate (2), or severe (3). Individual items are summed to generate a total score (0 to 36), with a higher score indicating worse dyspnea
Time frame: Baseline to 8 weeks
RAND-36 Quality of life
8 subdomains will be scored 0-100 with higher scores reflecting better perceived quality of life.
Time frame: Baseline to 8 weeks
FACIT-F
Version 4 is a 40-item measure that will be used to assess self-reported fatigue and its impact on daily activities and function over the past 7 days. It is a 5-point Likert-type scale with five subdomains including physical well-being, social/family well-being, emotional well-being, functional well-being, and fatigue yielding a total score from 0-52.
Time frame: Baseline to 8 weeks
The Ohio State University Comprehensive Cancer Center
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