DyspneaNCT04987125
Dyspnea Neuroscience Education on Patients With Chronic Obstructive Pulmonary Disease
A study testing Dyspnea Neuroscience education in people with Dyspnea, run by Cardenal Herrera University.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dyspnea
- What is being tested?
- Dyspnea Neuroscience education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Dyspnea
- Being tested
- Dyspnea Neuroscience education, Usual care
- Keywords
- Education, Neuroscience education
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyspnea Neuroscience educationBehavioural
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dyspnea Neuroscience education | Experimental | Not described Receives: Behavioral: Dyspnea Neuroscience education |
| Usual care | Active comparator | Not described Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Perception of Dyspnea questionnaire at 4 and weeks and 6 months
Measured: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Change from disability questionnaire at 4 and weeks and 6 months
Measured: 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
Measured: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Change from Level of Physical Activity questionnaire at 4 and weeks and 6 months
Measured: 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
Measured: 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
Measured: 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
Measured: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Change from FEV1 physiological parameter at 4 and weeks and 6 months
Measured: 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
Measured: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Suso, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987125
- Sponsor's protocol ID
- 1
- Status last verified
- Aug 2021
- First submitted
- 15 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyspnea Neuroscience Education on Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04987125
- Acronym / sponsor ID
- 1
- Conditions
- Dyspnea
- Keywords
- Education, Neuroscience education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyspnea Neuroscience education | Experimental | Behavioral: Dyspnea Neuroscience education |
| Usual care | Active comparator | Behavioral: Usual care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyspnea Neuroscience educationPatients 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. | Behavioural | Dyspnea Neuroscience education |
| Usual careGeneral 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. | Behavioural | Usual care |
Primary outcome
Change from Perception of Dyspnea questionnaire at 4 and weeks and 6 months
Time frame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Change from disability questionnaire at 4 and weeks and 6 months
Time frame: 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
Time frame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Change from Level of Physical Activity questionnaire at 4 and weeks and 6 months
Time frame: 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
Time frame: 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
Time frame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
3 secondary outcomes
Change from Forced vital capacity physiological parameter at 4 and weeks and 6 months
Time frame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Change from FEV1 physiological parameter at 4 and weeks and 6 months
Time frame: 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
Time frame: Preintervention, postintervention (4 weeks) and follow-up (6 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Dyspnea Neuroscience education in people with Dyspnea, run by Cardenal Herrera University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Suso-Martí, PhD (627819667, luis.suso@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Perception of Dyspnea questionnaire at 4 and weeks and 6 months (time frame: Preintervention, postintervention (4 weeks) and follow-up (6 months).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.