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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL176491-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to compare the impact of inspiratory muscle training (IMT) combined with cardiac rehabilitation (CR) on cardiovascular function in patients with heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspiratory muscle training (IMT) | Experimental | IMT performed at 40% maximal inspiratory pressure (MIP) for 30 minutes 3 days a week for 12 weeks. |
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| SHAM | Sham Comparator | IMT performed at 5% maximal inspiratory pressure (MIP) for 30 minutes 3 days a week for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Powerbreathe | Device | The breathing training will consist of using the PowerBreathe for 12 weeks. The PowerBreathe is an inspiratory pressure threshold trainer. The valve blocks the airflow until the threshold pressure is achieved by breathing in forcefully into the device. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in locomotor muscle blood flow during exercise | Locomotor muscle blood flows will be measured via Doppler-ultrasound. This will be measured in mL/min. | Baseline, 12 weeks |
| Change in respiratory muscle cost of breathing (VO2) | Respiratory muscle cost of breathing is the oxygen uptake (VO2) to the respiratory muscles. Respiratory muscle VO2 is expressed as milliliters of oxygen per kilogram of body mass per minute. | Baseline, 12 weeks |
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Inclusion Criteria
HFrEF Patients: (≥18 yrs) receiving guideline directed pharmacologic medical therapy for >6 weeks (those with contraindications to medical therapy will meet inclusion criteria), NYHA symptoms I-III, no hospitalizations in the >3 months, have a body mass index ≤45 kg/m2, currently be non-smokers with <30 pack year history and be able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise).
Exclusion Criteria
For individuals agreeing to undergo dual energy x-ray absorptiometry (DEXA) scanning for measurement of body composition as part of their study visit, additional exclusion criteria apply: recently administered gastrointestinal contrast or radionuclides; severe degenerative changes or fracture deformity in measurement areas; or inability to attain correct position and/or remain motionless for the measurement period.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Bruhn, M.A | Contact | 507-266-2690 | bruhn.eric@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joshua Smith, Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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