Inspiratory Muscle Strength Training in Adults With Obesity

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Device: High-resistance inspiratory muscle strength training; Device: Very-low-resistance inspiratory muscle strength training

• Registration Number: NCT05459636
• Lead Sponsor: Florida State University

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

Study Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-15
• Study Start: 2023-12-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2027-06-30
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-resistance inspiratory muscle strength training	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.
Very-low resistance inspiratory muscle strength training	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.

Primary Outcome Measures

Name	Time	Method
Change in laboratory-measured blood pressure	Up to 16 weeks	Systolic and diastolic blood pressure measured in the laboratory

Secondary Outcome Measures

Name	Time	Method
Change in inspiratory muscle strength	Up to 16 weeks	Peak inspiratory pressure measured in the laboratory
Blood pressure during respiratory muscle testing	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)
Change in ambulatory blood pressure	Up to 16 weeks	Systolic and diastolic blood pressure measured at home using an automated monitor
Change in blood pressure reactivity during aerobic exercise	Up to 16 weeks	Systolic and diastolic blood pressure measured in the laboratory at rest and during an incremental aerobic exercise test

Trial Locations

Locations (1)

Florida State University; 🇺🇸 Tallahassee, Florida, United States