Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure at 6 Weeks
研究概览
简要总结
This study will assess the dose-response effects of Inspiratory Muscle Strength Training (IMST) in adults with above-normal systolic blood pressure over a 6-week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Resting SBP ≥120 mmHg as measured during screening 1 & 2
- •Free from serious CV or metabolic diseases as identified by self-report and blood chemistry analysis.
- •No contraindications to IMST (recent abdominal surgery, ruptured eardrum, asthma with very low symptom perception, fractured ribs, or pneumothorax)
- •Language: English-speaking, with ability to comprehend study materials and instructions.
- •Pre-visit Compliance: Willing to comply with pre-visit instructions (avoiding food and caffeine ≥ 3 hours, vigorous exercise, alcohol, and non-prescribed medications ≥ 24 hours) prior to each measurement visit.
- •Lifestyle: Non-smokers (defined as self-report of not smoking cigarettes or vaping over the past year).
排除标准
- •Self-report of history of cardiovascular disease, or conditions affecting the ear (e.g., ruptured eardrum).
- •Recent abdominal surgery or presence of an abdominal hernia.
- •Asthma with very low symptom perception, frequent severe exacerbations, or abnormally low perception of dyspnea.
- •Ruptured eardrum or any other condition of the ear.
- •Markedly elevated left ventricular end-diastolic volume and pressure.
- •Current respiratory conditions such as a cold, sinusitis, or respiratory tract infection (participants may be included once they recover from the respiratory condition).
- •Female-Specific: Pregnant or planning to become pregnant during the study period.
- •Compliance: Unable or unwilling to comply with pre-visit restrictions (e.g., avoiding caffeine, alcohol, and exercise within specified hours before visits).
研究组 & 干预措施
15 Breaths/ Day
All sessions will be performed at 75% of each participant's PI max 7 days per week, for 6 weeks, using the POWERbreathe K5 device. Each session will take approximately 3-10 minutes depending on the assigned dose group.
干预措施: POWERbreathe K5 (Device)
30 Breaths/ Day
All sessions will be performed at 75% of each participant's PI max 7 days per week, for 6 weeks, using the POWERbreathe K5 device. Each session will take approximately 3-10 minutes depending on the assigned dose group.
干预措施: POWERbreathe K5 (Device)
45 Breaths/ Day
All sessions will be performed at 75% of each participant's PI max 7 days per week, for 6 weeks, using the POWERbreathe K5 device. Each session will take approximately 3-10 minutes depending on the assigned dose group.
干预措施: POWERbreathe K5 (Device)
结局指标
主要结局
Systolic Blood Pressure at 6 Weeks
时间窗: Week 6
To determine resting SBP before and after 6 weeks of IMST 15, IMST 30, or IMST 45 (75% PI max for all groups) in men and women aged ≥18 years with resting SBP ≥120 mmHg.
次要结局
未报告次要终点