Inspiratory Muscle Strength Training in Adults With Obesity

NCT05459636 | Recruiting FDA Device

• 2 other identifiers: STUDY00003098K01HL160772
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in laboratory-measured blood pressure

  Systolic and diastolic blood pressure measured in the laboratory

  Up to 16 weeks

Secondary Outcomes (4)

• Change in ambulatory blood pressure

  Up to 16 weeks

• Change in inspiratory muscle strength

  Up to 16 weeks

• Change in blood pressure reactivity during aerobic exercise

  Up to 16 weeks

• Blood pressure during respiratory muscle testing

  Up to 16 weeks

Study Arms (2)

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.

Device: High-resistance inspiratory muscle strength training

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.

Device: Very-low-resistance inspiratory muscle strength training

Interventions

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.

High-resistance inspiratory muscle strength training

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.

Very-low resistance inspiratory muscle strength training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Body mass index 30 - 40 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Joseph C Watso, PhD

CONTACT

850-644-5260; jwatso@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 15, 2022
• Study Start: December 7, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year after completion of trial, indefinitely
• Access Criteria: 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.

Locations

US (1)