Inspiratory Muscle Training in Obese Breast Cancer Survivors (IMOCS)

Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Breast Cancer; Cancer Survivors
• Intervention / Treatment: Behavioral: Inspiratory muscle training; Behavioral: Exercise training

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dharini M Bhammar, PhD; Phone Number: 6143669467; Email: dharini.bhammar@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
      • Principal Investigator: Dharini M Bhammar, PhD
      • Contact: Dharini M Bhammar, PhD; Phone Number: 614-366-9467; Email: bhammar.1@osu.edu
      • Principal Investigator: Sagar Sardesai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: Inspiratory muscle training; Training of respiratory muscles; Behavioral: Exercise training; Supervised aerobic exercise intervention
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	Behavioral: Exercise training; Supervised aerobic exercise intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in exercise tolerance	Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.	Baseline to 4 weeks
Change in exercise tolerance	Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.	Baseline to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inspiratory muscle strength	Continuous variable, Maximal inspiratory pressure. Units: cm H20	Baseline to 4 weeks
Change in inspiratory muscle strength	Continuous variable, Maximal inspiratory pressure. Units: cm H20	Baseline to 16 weeks
Change in inspiratory muscle endurance	Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min	Baseline to 4 weeks
Change in inspiratory muscle endurance	Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min	Baseline to 16 weeks
Change in exercise capacity	Continuous variable, peak oxygen uptake. Units: L/min	Baseline to 4 weeks
Change in exercise capacity	Continuous variable, peak oxygen uptake. Units: L/min	Baseline to 16 weeks
Change in dyspnea	Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4	Baseline to 4 weeks
Change in dyspnea	Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4	Baseline to 16 weeks
Change in fatigue	Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52	Baseline to 4 weeks
Change in fatigue	Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52	Baseline to 16 weeks

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Dharini M Bhammar, PhD, Ohio State University

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 31, 2021
• First Submitted That Met QC Criteria: December 31, 2021
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Neoplasms by Site; Neoplasms; Overnutrition; Body Weight; Skin Diseases; Breast Diseases; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Obesity; Breast Neoplasms; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: OSU-22220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will make deidentified data freely available if requested. The privacy and rights of the participants will be protected.
• IPD Sharing Time Frame: Data will become available after data collection is complete for up to 3 years.
• IPD Sharing Access Criteria: Deidentified data will be made available on request following approved data use agreements between institutions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No