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Dyspnea Neuroscience Education on Patients With Chronic Obstructive Pulmonary Disease

Primary Purpose

Dyspnea

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Dyspnea Neuroscience education

Usual care

About this trial

This is an interventional treatment trial for Dyspnea focused on measuring Education, Neuroscience education

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dyspnea Neuroscience education

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Change from Perception of Dyspnea questionnaire at 4 and weeks and 6 months

Change from disability questionnaire at 4 and weeks and 6 months

Change from Quality of Life about respiratory disease questionnaire at 4 and weeks and 6 months

Change from Level of Physical Activity questionnaire at 4 and weeks and 6 months

Change from Activity-related intensity and unpleasantness of perceived dyspnea questionnaire at 4 and weeks and 6 months

Change from Self-efficacy Scale for Physical Activity questionnaire at 4 and weeks and 6 months

Secondary Outcome Measures

Change from Forced vital capacity physiological parameter at 4 and weeks and 6 months

Change from FEV1 physiological parameter at 4 and weeks and 6 months

Change from Six Minute Walk Test (Sp02% Change) physiological parameter at 4 and weeks and 6 months

Full Information

NCT ID

NCT04987125

First Posted

July 15, 2021

Last Updated

August 3, 2021

Sponsor

Cardenal Herrera University

1. Study Identification

Unique Protocol Identification Number

NCT04987125

Brief Title

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

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2021 (Anticipated)

Primary Completion Date

April 1, 2022 (Anticipated)

Study Completion Date

May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cardenal Herrera University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyspnea

Keywords

Education, Neuroscience education

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dyspnea Neuroscience education

Arm Type

Experimental

Arm Title

Usual care

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Dyspnea Neuroscience education

Intervention Description

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

Intervention Name(s)

Usual care

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from Perception of Dyspnea questionnaire at 4 and weeks and 6 months

Time Frame