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RecruitingInterventional

Effects of Inspiratory Muscle Training Among Breast Cancer Patients Undergoing Active Treatment (IMACT)

NCT ID: NCT07386444Sponsor: Ohio State University Comprehensive Cancer CenterLast updated: 2026-04-06

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.

Arms & interventions

  • BehavioralInspiratory muscle training

    Training of respiratory muscles

Outcome measures

Primary

  • Maximum inspiratory pressure

    Measure of the strength of the inspiratory muscles. Units: cm H20

    Time frame: Baseline to 8 weeks

Secondary

  • Physical activity levels

    Time frame: Baseline to 8 weeks

  • Modified Medical Research Council Dyspnea scale rating

    Time frame: Baseline to 8 weeks

  • Dyspnea 12 score

    Time frame: Baseline to 8 weeks

  • RAND-36 Quality of life

    Time frame: Baseline to 8 weeks

  • FACIT-F

    Time frame: Baseline to 8 weeks

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy 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

Study locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Recruiting
Dharini M. Bhammar, MBBS, PhD · Contact
Dharini M. Bhammar, MBBS, PhD · Principal Investigator