Clinical trial NCT04987125: Dyspnea Neuroscience Education on Patients With Chronic Obstructive Pulmonary Disease
Official title: Dyspnea Neuroscience Education on Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dyspnea
Keywords: Education
Neuroscience education
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Perception of Dyspnea questionnaire at 4 and weeks and 6 months
timeFrame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
measure: Change from disability questionnaire at 4 and weeks and 6 months
timeFrame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
measure: Change from Quality of Life about respiratory disease questionnaire at 4 and weeks and 6 months
timeFrame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
measure: Change from Level of Physical Activity questionnaire at 4 and weeks and 6 months
timeFrame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
measure: Change from Activity-related intensity and unpleasantness of perceived dyspnea questionnaire at 4 and weeks and 6 months
timeFrame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
measure: Change from Self-efficacy Scale for Physical Activity questionnaire at 4 and weeks and 6 months
timeFrame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Secondary outcomes:
measure: Change from Forced vital capacity physiological parameter at 4 and weeks and 6 months
timeFrame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
measure: Change from FEV1 physiological parameter at 4 and weeks and 6 months
timeFrame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
measure: Change from Six Minute Walk Test (Sp02% Change) physiological parameter at 4 and weeks and 6 months
timeFrame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Other outcomes:
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