Dyspnea Neuroscience Education on Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Dyspnea Neuroscience Education on Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Dyspnea

Intervention / Treatment
-----------------
* Behavioral: Dyspnea Neuroscience education
* Behavioral: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dyspnea Neuroscience education<br> | Behavioral: Dyspnea Neuroscience education<br>* Patients will follow an online therapeutic education course about dyspnea. Education about the cognitive and emotional aspects of dyspnea processing, with the goal of changing maladaptive cognitions and behaviors. The course will be group-based (5 participants). The frequency will be of 1 session per week for 4 weeks, each session will have a duration of 1 hour.<br>|
| Active Comparator: Usual care<br> | Behavioral: Usual care<br>* General health advice, physiotherapy treatment. The frequency will be of 1 session per week for 4 weeks, each session will have a duration of 1 hour.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Perception of Dyspnea questionnaire at 4 and weeks and 6 months |  | Preintervention, postintervention (4 weeks) and follow-up (6 months). | 
| Change from disability questionnaire at 4 and weeks and 6 months |  | 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 |  | Preintervention, postintervention (4 weeks) and follow-up (6 months). | 
| Change from Level of Physical Activity questionnaire at 4 and weeks and 6 months |  | 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 |  | 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 |  | Preintervention, postintervention (4 weeks) and follow-up (6 months). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Education, Neuroscience education