Inspiratory Muscle Training in Obese Breast Cancer Survivors

Overview

The investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in stage 0-III obese breast cancer survivors. The investigators central hypothesis is that obesity promotes exercise intolerance via obesity-related impaired breathing mechanics and that inspiratory muscle training will be effective in improving impaired breathing mechanics and exercise tolerance..

Full Title of Study: “Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 30, 2027

Interventions

  • Behavioral: Inspiratory muscle training
    • Training of respiratory muscles
  • Behavioral: Exercise training
    • Supervised aerobic exercise intervention

Arms, Groups and Cohorts

  • Experimental: 16 wk IMT + 12 wk exercise
    • 16 weeks of IMT, 3/week, 3 sets of 15 repetitions, intensity up to 70% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity
  • Experimental: 4 wk IMT + 12 wk exercise
    • 4 weeks of IMT, 3/week, 3 sets of 15 repetitions, intensity up to 70% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity
  • Sham Comparator: 4 wk SHAM + 12 wk exercise
    • 4 weeks of SHAM training, 3/week, 3 sets of 15 repetitions, intensity up of 10% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity

Clinical Trial Outcome Measures

Primary Measures

  • Change in exercise tolerance
    • Time Frame: Baseline to 16 weeks
    • Continuous variable assessed as time to exhaustion during graded cycle ergometry. Units: minutes.

Secondary Measures

  • Change in inspiratory muscle strength
    • Time Frame: Baseline to 16 weeks
    • Continuous variable assessed at rest. Units: cm H20
  • Change in dynamic hyperinflation
    • Time Frame: Baseline to 16 weeks
    • Continuous variable assessed using inspiratory capacity (rest minus exercise). Units: mL
  • Change in expiratory flow limitation
    • Time Frame: Baseline to 16 weeks
    • Continuous variable assessed using the percent overlap between exercise tidal flow-volume loop and maximal expiratory flow-volume loop. Units: percentage
  • Change in fatigue
    • Time Frame: Baseline to 16 weeks
    • Continuous variable, global score in the brief fatigue inventory. Units: score 1 to 10
  • Change in quality of life
    • Time Frame: Baseline to 16 weeks
    • Continuous variable, total score of health and well being. Units: score 0 to 100
  • Change in dyspnea
    • Time Frame: Baseline to 16 weeks
    • Continuous variable measured using the Borg 0 – 10 ratings of perceived breathlessness scale. Units: Borg score 0 to 10

Participating in This Clinical Trial

Inclusion Criteria

  • breast cancer survivors ≥40 years – 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) Exclusion Criteria:

  • functional limitations that make independent exercise unsafe – 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

Gender Eligibility: Female

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ohio State University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dharini Bhammar, Assistant Professor – Ohio State University
  • Overall Official(s)
    • Dharini M Bhammar, PhD, Principal Investigator, Ohio State University
  • Overall Contact(s)
    • Dharini M Bhammar, PhD, 6143669467, dharini.bhammar@osumc.edu

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