Clinical trial NCT05459636: Inspiratory Muscle Strength Training in Adults With Obesity
Official title: Time-Efficient Inspiratory Muscle Strength Training as a New Approach to Lower Blood Pressure, Improve Respiratory Function, and Reduce Exertional Dyspnea in Adults With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether inspiratory muscle strength training reduces blood pressure in adults with obesity.

Detailed description: 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

Eligibility criteria: 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:

  * Patients who have undergone recent abdominal surgery and those with abdominal hernia.
  * Asthma patients who have a very low symptom perception and suffer from frequent, severe exacerbations or with an abnormally low perception of dyspnea.
  * If a patient is suffering from a ruptured eardrum or any other condition of the ear.
  * Patients with marked elevated left ventricular end-diastolic volume and pressure.
  * Patients with worsening heart failure signs and symptoms after training.
  * If an individual is suffering from a cold, sinusitis or respiratory tract infection, it is advised that they do not use the POWERbreathe device.

Primary outcomes:
measure: Change in laboratory-measured blood pressure
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Change in ambulatory blood pressure
timeFrame: Up to 16 weeks
measure: Change in inspiratory muscle strength
timeFrame: Up to 16 weeks
measure: Change in blood pressure reactivity during aerobic exercise
timeFrame: Up to 16 weeks
measure: Blood pressure during respiratory muscle testing
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References: