Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Slope of oxygen consumption - dyspnea during treadmill exercise.
研究概览
简要总结
Endorphins are naturally occurring narcotic substances that are released when individuals perform exercise. The hypothesis of the study is that endorphins reduce the severity of breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD). The initial five visits include familiarization and validation of a computerized system for patients to report dyspnea and leg discomfort continuously during exercise testing.
At Visits 6 and 7 blood is drawn to measure serum endorphin levels pre-exercise, end exercise, and 30 minutes after exercise. Normal saline or naloxone is given intravenously 5 minutes prior to exercise in a double-blinded design. The primary outcome is the slope of oxygen consumption - dyspnea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD
- •Ability to exercise
- •Ability to computer mouse to provide ratings
- •> 10 pack-years smoking
- •Baseline dyspnea index < 9
排除标准
- •Clinically significant comorbidities
研究组 & 干预措施
A: naloxone; B: normal saline
Arm A: IV naloxone Arm B: IV normal saline
干预措施: naloxone versus placebo (Drug)
A: naloxone; B: normal saline
Arm A: IV naloxone Arm B: IV normal saline
干预措施: intravenous injection of normal saline or naloxone (Drug)
结局指标
主要结局
Slope of oxygen consumption - dyspnea during treadmill exercise.
时间窗: throughout exercise
次要结局
- Exercise duration(10-14 minutes)
- Peak ratings of breathlessness(at end of exercsie - 10-15 minutes)