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.
Conditions:
🦠 Cancer Survivors 🦠 Obesity 🦠 Breast Cancer
🗓️ Study Start (Actual) 13 November 2023
🗓️ Primary Completion (Estimated) 30 June 2028
✅ Study Completion (Estimated) 30 June 2029
👥 Enrollment (Estimated) 78
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Columbus, Ohio, United States

📋 Eligibility Criteria

Description

    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
    • * current smokers
    • * metastatic breast cancer
    • * ongoing or active infection with recent antibiotics or steroids
    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 31 December 2021
  • First Submitted that Met QC Criteria 31 December 2021
  • First Posted 14 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 November 2023
  • Last Update Posted 18 November 2023
  • Last Verified November 2023