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| ID | Type | Description | Link |
|---|---|---|---|
| K01HL160772 | 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 determine whether inspiratory muscle strength training reduces blood pressure in adults with obesity.
Obesity affects four-in-ten American adults and is associated with hypertension and greater all-cause mortality. Irrespective of weight loss, aerobic exercise reduces arterial blood pressure (BP) and improves cardiometabolic health. However, nearly half of adults with obesity do not perform aerobic exercise because of low leisure time availability and exertional dyspnea secondary to high chest wall mass-related inspiratory muscle dysfunction. In other clinical populations, emerging data demonstrates time-efficient high-resistance inspiratory muscle strength training (IMST) reduces BP and improves respiratory muscle function. Therefore, the investigators will determine whether eight weeks of daily high-resistance IMST reduces BP, improves respiratory muscle function, and concomitantly reduces exertional dyspnea in a randomized, double-blinded, sham-controlled (i.e., very low-resistance IMST) clinical trial among adults with obesity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-resistance inspiratory muscle strength training | Active Comparator | Participants will perform high-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in. |
|
| Very-low resistance inspiratory muscle strength training | Sham Comparator | Participants will perform very-low-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-resistance inspiratory muscle strength training | Device | Participants will perform high-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in laboratory-measured blood pressure | Systolic and diastolic blood pressure measured in the laboratory | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ambulatory blood pressure | Systolic and diastolic blood pressure measured at home using an automated monitor | Up to 16 weeks |
| Change in inspiratory muscle strength | Peak inspiratory pressure measured in the laboratory |
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Inclusion Criteria:
- Body mass index 30 - 40 kg/m2
Exclusion Criteria:
Not weight stable (<5% change in body mass over the past six months)
Overt cardiovascular, neurological, renal, liver, and/or metabolic illness (e.g., diabetes mellitus)
Current, or history of uncontrolled, Stage 2 hypertension (blood pressure >140 / 90 mmHg; anti-hypertensive medications are permitted)
Diagnosed obstructive sleep apnea
Previous bariatric surgery
Diagnosis or signs (e.g., values below the lower limit of normal) of overt airway disease(s)
Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes, vaping)
Pregnant (self-reported and confirmed via urine pregnancy test), lactating (self-reported), or post-menopausal (self-reported) females
Prisoners
Per the POWERbreathe® company:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph C Watso, PhD | Contact | 850-644-5260 | jwatso@fsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Recruiting | Tallahassee | Florida | 32306 | United States |
Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
One year after completion of trial, indefinitely
A formal plan identifying the intended use of the data and proper completion of appropriate data and/or material transfer agreement approvals with the study PI and their institution.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Very-low-resistance inspiratory muscle strength training | Device | Participants will perform very-low-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in. |
|
| Up to 16 weeks |
| Change in blood pressure reactivity during aerobic exercise | Systolic and diastolic blood pressure measured in the laboratory at rest and during an incremental aerobic exercise test | Up to 16 weeks |
| Blood pressure during respiratory muscle testing | Systolic and diastolic blood pressure measured in the laboratory at rest and during a respiratory muscle exercise test (eucapnic voluntary hyperpnea) | Up to 16 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |