Inspiratory Muscle Training in Patients With Pulmonary Hypertension: a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- exercise capacity - 6-min walk test
研究概览
简要总结
Inspiratory muscle training for 8 weeks in patients with pulmonary hypertension.
详细描述
32 patients with PH will perform: 1) pulmonary function tests; 2) measurement of maximal inspiratory pressure (MIP) and endurance; 3) six-minute walk test and 5) incremental and constant load cardiopulmonary exercise test (~ 75% of maximal work-rate) and step test. Inspiratory muscle training will consist of twice daily sessions of 30 breaths (~ 50% PiMAX, 4-5 minutes per session) for 8 weeks. The SHAM group will perform sessions of 30 breaths with no inspiratory load.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CTEPH confirmed by RHC and imaging
- •NYHA FC II-IV
排除标准
- •Limitation to cycling
- •Recent syncope or clinical deterioration
研究组 & 干预措施
Experimental: IMT
inspiratory muscle training (PowerBREATHE) with ~50% of maximum inspiratory pressure
干预措施: inspiratory muscle training (Other)
Placebo: SHAM
inspiratory muscle training (PowerBREATHE) without inspiratory load
干预措施: Placebo "training" (Other)
结局指标
主要结局
exercise capacity - 6-min walk test
时间窗: week 8
distance (m)
exercise capacity¨- cardiopulmonary exercise testing
时间窗: week 8
TLim (seconds)
次要结局
- ventilatory responses(Week 8)
- ventilatory responses(Week 8)
研究者
Roberta Pulcheri Ramos
Professor
Federal University of São Paulo