NCT04987125

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

July 15, 2021

Last Update Submit

August 3, 2021

Conditions

Dyspnea

Keywords

EducationNeuroscience education

Outcome Measures

Primary Outcomes (6)

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

    Preintervention, postintervention (4 weeks) and follow-up (6 months).

Secondary Outcomes (3)

  • 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 FEV1 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).

Study Arms (2)

Dyspnea Neuroscience education

EXPERIMENTAL
Behavioral: Dyspnea Neuroscience education

Usual care

ACTIVE COMPARATOR
Behavioral: Usual care

Interventions

Dyspnea Neuroscience educationBEHAVIORAL

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.

Dyspnea Neuroscience education
Usual careBEHAVIORAL

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.

Usual care

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Luis Suso-Martí, PhD

CONTACT

627819667luis.suso@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2021

First Posted

August 3, 2021

Study Start

October 1, 2021

Primary Completion

April 1, 2022

Study Completion

May 1, 2022

Last Updated

August 9, 2021

Record last verified: 2021-08