Inspiratory Muscle Strength Training in Adults With Obesity

NCT ID: NCT05459636

Last Updated: 2026-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-07
• Study Completion Date: 2027-07-31

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

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

High-resistance inspiratory muscle strength training

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.

Group Type: ACTIVE_COMPARATOR

High-resistance inspiratory muscle strength training

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

Very-low-resistance inspiratory muscle strength training

Intervention Type: 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.

Interventions

High-resistance inspiratory muscle strength training

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.

Intervention Type: DEVICE

Very-low-resistance inspiratory muscle strength training

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Joseph Watso

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Florida State University

Tallahassee, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joseph C Watso, PhD

Role: CONTACT

jwatso@fsu.edu

850-644-5260

Facility Contacts

Joseph Watso

Role: primary

Other Identifiers

K01HL160772

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003098

Identifier Type: -

Identifier Source: org_study_id