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NCT Number: NCT05193149

Inspiratory Muscle Training in Obese Breast Cancer Survivors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • metastatic breast cancer
  • ongoing or active infection with recent antibiotics or steroids
  • Bilateral Axillary lymph node dissection (ALND) of >5 lymph nodes on each side, which could increase risk of lymphadenopathy with repeated blood pressure measurements during exercise or if patient has been advised by their clinician to avoid repeated BP measures on both arms. Bilateral Sentinel Lymph Node Biopsy (SLNB) will be allowed.
  • 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

Treatment and study plan

Inspiratory Muscle Training

Behavioral

Training of respiratory muscles

Exercise Training

Behavioral

Supervised aerobic exercise intervention

Primary outcomes

  1. Change in exercise tolerance

    Time frame: Baseline to 4 weeks

    Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.

  2. Change in exercise tolerance

    Time frame: Baseline to 16 weeks

    Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.

Secondary outcomes

  1. Change in inspiratory muscle strength

    Time frame: Baseline to 4 weeks

    Continuous variable, Maximal inspiratory pressure. Units: cm H20

  2. Change in inspiratory muscle strength

    Time frame: Baseline to 16 weeks

    Continuous variable, Maximal inspiratory pressure. Units: cm H20

  3. Change in inspiratory muscle endurance

    Time frame: Baseline to 4 weeks

    Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min

  4. Change in inspiratory muscle endurance

    Time frame: Baseline to 16 weeks

    Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min

  5. Change in exercise capacity

    Time frame: Baseline to 4 weeks

    Continuous variable, peak oxygen uptake. Units: L/min

  6. Change in exercise capacity

    Time frame: Baseline to 16 weeks

    Continuous variable, peak oxygen uptake. Units: L/min

  7. Change in dyspnea

    Time frame: Baseline to 4 weeks

    Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4

  8. Change in dyspnea

    Time frame: Baseline to 16 weeks

    Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4

  9. Change in fatigue

    Time frame: Baseline to 4 weeks

    Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52

  10. Change in fatigue

    Time frame: Baseline to 16 weeks

    Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer

Acronym: IMOCS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2022
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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