Inspiratory Muscle Training in Obese Breast Cancer Survivors (IMOCS)
Primary Purpose
Cancer Survivors, Obesity, Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspiratory muscle training
Exercise training
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer Survivors
Eligibility Criteria
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 & nonobese as defined as BMI 18.5 to 24.9 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
Sites / Locations
- The Ohio State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
4 wk IMT + 12 wk exercise
4 wk SHAM + 12 wk exercise
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change in exercise tolerance
Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.
Change in exercise tolerance
Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.
Secondary Outcome Measures
Change in inspiratory muscle strength
Continuous variable, Maximal inspiratory pressure. Units: cm H20
Change in inspiratory muscle strength
Continuous variable, Maximal inspiratory pressure. Units: cm H20
Change in inspiratory muscle endurance
Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min
Change in inspiratory muscle endurance
Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min
Change in exercise capacity
Continuous variable, peak oxygen uptake. Units: L/min
Change in exercise capacity
Continuous variable, peak oxygen uptake. Units: L/min
Change in dyspnea
Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4
Change in dyspnea
Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4
Change in fatigue
Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52
Change in fatigue
Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52
Full Information
NCT ID
NCT05193149
First Posted
December 31, 2021
Last Updated
September 7, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05193149
Brief Title
Inspiratory Muscle Training in Obese Breast Cancer Survivors
Acronym
IMOCS
Official Title
Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
June 30, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivors, Obesity, Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Staff completing outcomes testing and study participants will be blinded to treatment assignment (IMT/SHAM). The IMT/SHAM devices are the same with ability to alter resistance; however, upon use at the lower intensity, the participant may be able to tell whether the device has resistance.
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
4 wk IMT + 12 wk exercise
Arm Type
Experimental
Arm Description
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
Arm Title
4 wk SHAM + 12 wk exercise
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Inspiratory muscle training
Intervention Description
Training of respiratory muscles
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Supervised aerobic exercise intervention
Primary Outcome Measure Information:
Title
Change in exercise tolerance
Description
Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.
Time Frame
Baseline to 4 weeks
Title
Change in exercise tolerance
Description
Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.
Time Frame
Baseline to 16 weeks
Secondary Outcome Measure Information:
Title
Change in inspiratory muscle strength
Description
Continuous variable, Maximal inspiratory pressure. Units: cm H20
Time Frame
Baseline to 4 weeks
Title
Change in inspiratory muscle strength
Description
Continuous variable, Maximal inspiratory pressure. Units: cm H20
Time Frame
Baseline to 16 weeks
Title
Change in inspiratory muscle endurance
Description
Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min
Time Frame
Baseline to 4 weeks
Title
Change in inspiratory muscle endurance
Description
Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min
Time Frame
Baseline to 16 weeks
Title
Change in exercise capacity
Description
Continuous variable, peak oxygen uptake. Units: L/min
Time Frame
Baseline to 4 weeks
Title
Change in exercise capacity
Description
Continuous variable, peak oxygen uptake. Units: L/min
Time Frame
Baseline to 16 weeks
Title
Change in dyspnea
Description
Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4
Time Frame
Baseline to 4 weeks
Title
Change in dyspnea
Description
Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4
Time Frame
Baseline to 16 weeks
Title
Change in fatigue
Description
Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52
Time Frame
Baseline to 4 weeks
Title
Change in fatigue
Description
Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52
Time Frame
Baseline to 16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dharini M Bhammar, PhD
Phone
6143669467
Email
dharini.bhammar@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dharini M Bhammar, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dharini M Bhammar, PhD
Phone
614-366-9467
Email
bhammar.1@osu.edu
First Name & Middle Initial & Last Name & Degree
Dharini M Bhammar, PhD
First Name & Middle Initial & Last Name & Degree
Sagar Sardesai, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
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Inspiratory Muscle Training in Obese Breast Cancer Survivors
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