Effects of Inspiratory Muscle Training Among Breast Cancer Patients Undergoing Active Treatment (IMACT)
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Maximum inspiratory pressure
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Masking Description
Participants will be blinded to the intervention.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Within 3 weeks of starting chemotherapy for an early-stage breast cancer diagnosis
- •Able to exercise independently without needing support
- •Ability to read, speak, understand English
Exclusion Criteria
- •Metastatic breast cancer
- •Unwilling or unable to follow protocol requirements
- •Any significant health condition which in the investigator's opinion increases the risks of participation or makes the participant unsuitable for the study
Arms & Interventions
Arm 1 (low-intensity IMT)
Patients complete three sets of fifteen repetitions per session of low-intensity IMT over 15-20 minutes four days a week for 8 weeks.
Intervention: Inspiratory muscle training (Behavioral)
Arm 2 (high-intensity IMT)
Patients complete three sets of fifteen repetitions per session of high-intensity IMT over 15-20 minutes four days a week for 8 weeks.
Intervention: Inspiratory muscle training (Behavioral)
Outcomes
Primary Outcomes
Maximum inspiratory pressure
Time Frame: Baseline to 8 weeks
Measure of the strength of the inspiratory muscles. Units: cm H20
Secondary Outcomes
- Physical activity levels(Baseline to 8 weeks)
- Modified Medical Research Council Dyspnea scale rating(Baseline to 8 weeks)
- Dyspnea 12 score(Baseline to 8 weeks)
- RAND-36 Quality of life(Baseline to 8 weeks)
- FACIT-F(Baseline to 8 weeks)
Investigators
Dharini Bhammar
Principal Investigator
Ohio State University Comprehensive Cancer Center