Dyspnea Neuroscience Education on Patients With Chronic Obstructive Pulmonary Disease

Dyspnea Clinical Trial

Official title:

Dyspnea Neuroscience Education on Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04987125
• Other study ID #: 1
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2021
• Source: Cardenal Herrera University
• Contact: Luis Suso-Martí, PhD
• Phone: 627819667
• Email: luis.suso[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Dyspnea Neuroscience education
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.
• Usual care
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Perception of Dyspnea questionnaire at 4 and weeks and 6 months		Preintervention, postintervention (4 weeks) and follow-up (6 months).
Primary	Change from disability questionnaire at 4 and weeks and 6 months		Preintervention, postintervention (4 weeks) and follow-up (6 months).
Primary	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).
Primary	Change from Level of Physical Activity questionnaire at 4 and weeks and 6 months		Preintervention, postintervention (4 weeks) and follow-up (6 months).
Primary	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).
Primary	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	Change from Forced vital capacity physiological parameter at 4 and weeks and 6 months		Preintervention, postintervention (4 weeks) and follow-up (6 months).
Secondary	Change from FEV1 physiological parameter at 4 and weeks and 6 months		Preintervention, postintervention (4 weeks) and follow-up (6 months).
Secondary	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).