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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
78
Training of respiratory muscles
Supervised aerobic exercise intervention
The Ohio State University
Columbus, Ohio, United States
RECRUITINGChange in exercise tolerance
Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.
Time frame: Baseline to 4 weeks
Change in exercise tolerance
Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.
Time frame: Baseline to 16 weeks
Change in inspiratory muscle strength
Continuous variable, Maximal inspiratory pressure. Units: cm H20
Time frame: Baseline to 4 weeks
Change in inspiratory muscle strength
Continuous variable, Maximal inspiratory pressure. Units: cm H20
Time frame: Baseline to 16 weeks
Change in inspiratory muscle endurance
Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min
Time frame: Baseline to 4 weeks
Change in inspiratory muscle endurance
Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min
Time frame: Baseline to 16 weeks
Change in exercise capacity
Continuous variable, peak oxygen uptake. Units: L/min
Time frame: Baseline to 4 weeks
Change in exercise capacity
Continuous variable, peak oxygen uptake. Units: L/min
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Time frame: Baseline to 16 weeks
Change in dyspnea
Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4
Time frame: Baseline to 4 weeks
Change in dyspnea
Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4
Time frame: Baseline to 16 weeks
Change in fatigue
Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52
Time frame: Baseline to 4 weeks
Change in fatigue
Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52
Time frame: Baseline to 16 weeks