Inspiratory Muscle Strength Training in Adults With Obesity

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459636
• Other study ID #: STUDY00003098
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: June 2024
• Source: Florida State University
• Contact: Joseph C Watso, PhD
• Phone: 850-644-5260
• Email: jwatso[@]fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: July 31, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• 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
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.

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in laboratory-measured blood pressure	Systolic and diastolic blood pressure measured in the laboratory	Up to 16 weeks
Secondary	Change in ambulatory blood pressure	Systolic and diastolic blood pressure measured at home using an automated monitor	Up to 16 weeks
Secondary	Change in inspiratory muscle strength	Peak inspiratory pressure measured in the laboratory	Up to 16 weeks
Secondary	Change in blood pressure reactivity during aerobic exercise	Systolic and diastolic blood pressure measured in the laboratory at rest and during an incremental aerobic exercise test	Up to 16 weeks
Secondary	Blood pressure during respiratory muscle testing	Systolic and diastolic blood pressure measured in the laboratory at rest and during a respiratory muscle exercise test (eucapnic voluntary hyperpnea)	Up to 16 weeks