IMOCS: Inspiratory Muscle Training in Obese Breast Cancer Survivors
Study Details
Study Description
Brief Summary
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..
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Behavioral: Inspiratory muscle training
Training of respiratory muscles
Behavioral: Exercise training
Supervised aerobic exercise intervention
|
| 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
|
Outcome Measures
Primary Outcome Measures
- Change in exercise tolerance [Baseline to 16 weeks]
Continuous variable assessed as time to exhaustion during graded cycle ergometry. Units: minutes.
Secondary Outcome Measures
- Change in dyspnea [Baseline to 16 weeks]
Continuous variable measured using the Borg 0 - 10 ratings of perceived breathlessness scale. Units: Borg score 0 to 10. Higher score is worse and indicates greater dyspnea.
- Change in inspiratory muscle strength [Baseline to 16 weeks]
Continuous variable assessed at rest. Units: cm H20
- Change in dynamic hyperinflation [Baseline to 16 weeks]
Continuous variable assessed using inspiratory capacity (rest minus exercise). Units: mL
- Change in expiratory flow limitation [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 [Baseline to 16 weeks]
Continuous variable, global score in the "brief fatigue inventory". Units: score 1 to 10. Higher score is worse.
- Change in fatigue [Baseline to 16 weeks]
Continuous variable, from the "PROMIS fatigue" questionnaire. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. Individual items are scored from 1 (not at all) to 5 (very much). Raw scores are calculating by summing individual items. Higher score is worse. Raw scores are converted to T-scores to allow comparisons with the general population.
- Change in quality of life [Baseline to 16 weeks]
Continuous variable, total score of health and well being using the RAND-36 quality of life questionnaire. Units: score 0 to 100. Lower score is worse.
- Change in quality of life [Baseline to 16 weeks]
Continuous variable, from the PROMIS Global-10 quality of life questionnaire. It consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived QOL. The scoring system of 1 (poor) to 5 (excellent) allows each of the individual items to be examined separately to provide specific information about perceptions of physical function, pain, fatigue, emotional distress, social health, and general perceptions of health. In addition 4 questions are summed to provide a global physical health raw score (Units: 0 to 20, higher is better) and 4 questions are summed to provide a global mental health raw score (Units: 0 to 20, higher is better). Raw scores are converted to T-scores to allow comparisons with the general population.
- Change in activity levels [Baseline to 16 weeks]
The International Physical Activity Questionnaire for adults assesses the physical activities (vigorous, mod-erate, and walking) and sitting time that people do as part of their daily lives for the past 7 days. The questionnaire estimates: 1) total physical activity in the units of MET-min/week (where 1 MET-min equals 1 min of resting energy expenditure and greater MET-min indicate higher levels of activity) and 2) time spent sitting in the unit of minutes with more time spent sitting considered to be a negative outcome.
Eligibility Criteria
Criteria
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:
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functional limitations that make independent exercise unsafe
-
metastatic breast cancer
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ongoing or active infection with recent antibiotics or steroids
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heart disease precluding exercise (congestive heart failure, unstable angina pectoris, cardiac arrhythmia)
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psychiatric illness/social situations that would limit compliance with study requirements
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orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise
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unwilling or unable to follow protocol requirements
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pregnant or nursing
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any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Ohio State University | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Ohio State University
Investigators
- Principal Investigator: Dharini M Bhammar, PhD, Ohio State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 55054