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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 wk IMT + 12 wk exercise | Experimental | 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 wk SHAM + 12 wk exercise | Sham Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory muscle training | Behavioral | Training of respiratory muscles |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dharini M Bhammar, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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We will make deidentified data freely available if requested. The privacy and rights of the participants will be protected.
Data will become available after data collection is complete for up to 3 years.
Deidentified data will be made available on request following approved data use agreements between institutions.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
| Exercise training |
| Behavioral |
Supervised aerobic exercise intervention |
|
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |