Dyspnea Neuroscience Education on Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Change from Level of Physical Activity questionnaire at 4 and weeks and 6 months
研究概览
简要总结
The principal aim of this study was to adapt pain neuroscience education to dyspnea, Dyspnea Neuroscience Education (DNE), and measure its effect on dyspnea perception, physica l activity level, disability, quality of life and ventilatory and functional capacity through a randomized controlled trial. The secondary objectives were to evaluate its feasibility and its effect on emotional state (anxiety and depression), medical atten dance, number of exacerbations and the willingness to exercise.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic of COPD by a physician or pneumologist
- •Stage 1, 2 or 3 on the GOLD Classification
- •GOLD Stage and FEV1 assessed by a physician in the last three months
- •Access to a computer and internet
排除标准
- •Cognitive impairment (MoCA-S score < 21)
- •Depression disorder (PHQ-9 score ≥11)
- •Generalized Anxiety Disorder (GAD-7 score ≥10)
- •Instable comorbidities preventing physical activities
- •Had a surgery in the past three months
- •Had an exacerbation in the past three months
- •Currently quitting tobacco
- •Use of oxygenation
结局指标
主要结局
Change from Level of Physical Activity questionnaire at 4 and weeks and 6 months
时间窗: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Change from Activity-related intensity and unpleasantness of perceived dyspnea questionnaire at 4 and weeks and 6 months
时间窗: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Change from Quality of Life about respiratory disease questionnaire at 4 and weeks and 6 months
时间窗: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Change from disability questionnaire at 4 and weeks and 6 months
时间窗: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Change from Perception of Dyspnea questionnaire at 4 and weeks and 6 months
时间窗: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Change from Self-efficacy Scale for Physical Activity questionnaire at 4 and weeks and 6 months
时间窗: Preintervention, postintervention (4 weeks) and follow-up (6 months).
次要结局
- Change from Forced vital capacity physiological parameter at 4 and weeks and 6 months(Preintervention, postintervention (4 weeks) and follow-up (6 months).)
- Change from FEV1 physiological parameter at 4 and weeks and 6 months(Preintervention, postintervention (4 weeks) and follow-up (6 months).)
- Change from Six Minute Walk Test (Sp02% Change) physiological parameter at 4 and weeks and 6 months(Preintervention, postintervention (4 weeks) and follow-up (6 months).)
研究者
Luis Suso
Principal Investigator
Cardenal Herrera University