Inspiratory Muscle Strength Training in Adults With Obesity

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

Overview

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

Interventions

• 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.
• 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.

Primary outcome measures

• Change in laboratory-measured blood pressure [Time frame: Up to 16 weeks]

Secondary outcome measures (4)

• Change in ambulatory blood pressure [Time frame: Up to 16 weeks]
• Change in inspiratory muscle strength [Time frame: Up to 16 weeks]
• Change in blood pressure reactivity during aerobic exercise [Time frame: Up to 16 weeks]
• Blood pressure during respiratory muscle testing [Time frame: Up to 16 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Basic science

Study locations

United States · 1 center

• Florida State University — Tallahassee

Identifiers

NCT: NCT05459636 · STUDY00003098 · K01HL160772

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗