Dyspnea Neuroscience Education on Patients With Chronic Obstructive Pulmonary Disease

Not Applicable

• Conditions: Dyspnea
• Interventions: Behavioral: Usual care; Behavioral: Dyspnea Neuroscience education

• Registration Number: NCT04987125
• Lead Sponsor: Cardenal Herrera University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-23
• Status Verified: 2021-08
• Study First Posted: 2021-08-03
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-09
• Study Start: 2021-10-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	-
Dyspnea Neuroscience education	Dyspnea Neuroscience education	-

Primary Outcome Measures

Name	Time	Method
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 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 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 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

Name	Time	Method
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 Six Minute Walk Test (Sp02% Change) 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).