Dyspnea Neuroscience Education on Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT04987125

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-05-01

Brief Summary

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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

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Conditions

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Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dyspnea Neuroscience education

Group Type EXPERIMENTAL

Dyspnea Neuroscience education

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardenal Herrera University

OTHER

Sponsor Role lead

Responsible Party

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Luis Suso

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Luis Suso-Martí, PhD

Role: CONTACT

627819667

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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