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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Change in laboratory-measured blood pressure
研究概览
简要总结
The purpose of this study is to determine whether inspiratory muscle strength training reduces blood pressure in adults with obesity.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Body mass index 30 - 40 kg/m2
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: High-resistance inspiratory muscle strength training (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.
干预措施: Very-low-resistance inspiratory muscle strength training (Device)
结局指标
主要结局
Change in laboratory-measured blood pressure
时间窗: Up to 16 weeks
Systolic and diastolic blood pressure measured in the laboratory
次要结局
- Change in inspiratory muscle strength(Up to 16 weeks)
- Blood pressure during respiratory muscle testing(Up to 16 weeks)
- Change in ambulatory blood pressure(Up to 16 weeks)
- Change in blood pressure reactivity during aerobic exercise(Up to 16 weeks)
研究者
Joseph Watso
Assistant Professor
Florida State University