Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximal inspiratory mouth pressure (MIP) measured in cmH2O
研究概览
简要总结
The purpose of this research is to study the effect of training the inspiratory muscles (i.e. the muscle that allow you to breath-in) on exercise capacity, quality of life, and short-term clinical outcomes in patients post lung transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
This is a double-blinded, randomized study
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
- •- All patients who undergo single- or double-lung transplant at Mayo Clinic Florida.
排除标准
- •Patients who do not survive the intra-operative period during the transplant surgery.
- •Patients undergoing retransplantation.
- •Patients undergoing multiorgan transplantation.
- •Patients who are not willing to or who are unable to give written informed consent.
研究组 & 干预措施
12-weeks pulmonary rehabilitation training plus inspiratory muscle training
To assess maximum inspiratory pressure, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home.
干预措施: POWERBreathe Plus® (Device)
12-weeks pulmonary rehabilitation training plus inspiratory muscle training
To assess maximum inspiratory pressure, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home.
干预措施: Cardiopulmonary rehabilitation post lung transplant (Other)
12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle
To assess maximum inspiratory pressure with placebo, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home. The resistance will be set to about 5% throughout the study.
干预措施: POWERBreathe Plus® (Device)
12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle
To assess maximum inspiratory pressure with placebo, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home. The resistance will be set to about 5% throughout the study.
干预措施: Cardiopulmonary rehabilitation post lung transplant (Other)
结局指标
主要结局
Maximal inspiratory mouth pressure (MIP) measured in cmH2O
时间窗: 12 weeks
The maximal strength generating capacity of the inspiratory muscles.
次要结局
- Maximal oxygen uptake (V̇O2max) measured in mL/kg/min(12 weeks)