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NCT Number: NCT05459636

Inspiratory Muscle Strength Training in Adults With Obesity

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

Location status: Recruiting

Location contact

Joseph Watso

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in laboratory-measured blood pressure

    Time frame: Up to 16 weeks

    Systolic and diastolic blood pressure measured in the laboratory

Secondary outcomes

  1. Change in ambulatory blood pressure

    Time frame: Up to 16 weeks

    Systolic and diastolic blood pressure measured at home using an automated monitor

  2. Change in inspiratory muscle strength

    Time frame: Up to 16 weeks

    Peak inspiratory pressure measured in the laboratory

  3. Change in blood pressure reactivity during aerobic exercise

    Time frame: Up to 16 weeks

    Systolic and diastolic blood pressure measured in the laboratory at rest and during an incremental aerobic exercise test

  4. Blood pressure during respiratory muscle testing

    Time frame: Up to 16 weeks

    Systolic and diastolic blood pressure measured in the laboratory at rest and during a respiratory muscle exercise test (eucapnic voluntary hyperpnea)

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph C Watso, PhD

CONTACT

[email protected]

850-644-5260

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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