Chronic Obstructive Pulmonary DiseaseDVDNCT01902927
Modulation of Dyspnea Perception During Exercise in COPD Patients Using Attentional Distraction
A study testing Attentional distraction using IAPS protocol (standardized images) in people with Chronic Obstructive Pulmonary Disease, run by Laval University at 1 site in Canada.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a major health problem whose prevalence is increasing rapidly. The gradual decrease in exercise tolerance is one of the usual consequences of COPD that affects the functional independence and quality of life of patients. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Attentional distraction using IAPS protocol (standardized images)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Oct 2013
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoking history > 10 pack-years
- Post-BD FEV1 [30-80 % predicted value]
- Post-BD FEV1/FVC < 70 %
- Age [50-80 yrs]
- Voorips score < 9
Who cannot join
- Exacerbation < 4 weeks
- Asthma, Neoplasia, Cardiac failure, Diabetes
- Neuromuscular limitations
- Major depression or other psychiatric disorders
- BMI > 30 kg/m2
- PaO2 < 60 mmHg or oxygenotherapy
- Involvement in a structured and regular physical activity program
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V 4G5
Philippe Gagnon, PhD, 418-656-8711 ext. 2672, philippe.gagnon.1@ulaval.ca
Didier Saey, PhD, 418-656-8711 ext. 2614, dider.saey@rea.ulaval.ca
About this study
Official title: Modulation of Dyspnea Perception During Exercise in COPD Patients Using Attentional Distraction : a Pilot Study
Chronic obstructive pulmonary disease (COPD) is a major health problem whose prevalence is increasing rapidly. The gradual decrease in exercise tolerance is one of the usual consequences of COPD that affects the functional independence and quality of life of patients.
In COPD patients, breathlessness and muscle fatigue are the main symptoms limiting exercise. Recent studies have shown that most of the physiological mechanisms of psychological factors such as emotions, motivation, memory, personality, expectations, or prior experience can greatly influence and modulate the perception of breathlessness. It has been proposed that the attentional distraction (visual or auditory) during exercise may be associated with a decrease in anxiety and shortness of breath and could improve exercise tolerance in COPD. We therefore propose to study the impact of attentional strategies of distraction on the perception of dyspnea and walking tolerance in patients with COPD.
Read more
The research hypotheses are:
- Compared with exposure to a strategy of negative attentional distraction during exercise, exposure to a strategy of positive attentional distraction will improve walking exercise tolerance in patients with COPD; ii) For a given level of effort, sensory perception and emotional perception will be enhanced by exposure to a strategy of positive attentional distraction.
Ten subjects with moderate to severe COPD will be recruited at the Research Center of the Institut Universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ). During an assessment visit, we will measure complete pulmonary function, body composition and maximal functional capacity during a maximal incremental test work performed on a treadmill.
During two subsequent experimental visits, and after spirometry control, participants will perform a walking test performed on a treadmill at an intensity corresponding to 75% of maximum effort during maximal incremental test. The test will be carried out in combination with a strategy of either positive attentional distraction, neutral attentional distraction or negative attentional distraction . The order of the condition will be randomized.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Attentional distraction using IAPS protocol (standardized images)
- Keywords
- Exercise tolerance, Dyspnea, Affective distraction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attentional distraction using IAPS protocol (standardized images)Other
Positive, Negative and Neutral Attentional distraction will be presented using IAPS protocol (standardized images) during exercise tests
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Experimental | COPD patients will perform a constant workrate treadmill exercise test until exhaustion with positve/neutral/negative visual distraction images during the exercise test assigned in a randomized order Receives: Other: Attentional distraction using IAPS protocol (standardized images) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance
The exercise tolerance (sec) will be defined as the time to exhaustion following a standardized constant workrate treadmill walking test corresponding to 75 % of maximal workload previously determined.
Measured: During each experimental visit (V2-V3-V4), from the start to the end of the exercise test (limited by symptoms of the patients). Participants will be followed for an expected period of 3 weeks (from date of randomization to the completion of the study)
Secondary outcomes (2)
Dyspnea perception
The dyspnea intensity will be measured using a 10-point Borg scale during the exercise test
Measured: During visit 2-3-4, from start to end of the endurance exercise test at every 90-sec intervals, up to 20 minutes. Participants will be followed for an expected period of 3 weeks (from date of randomization to the completion of the study)
Dyspnea affective perception
The affective perception of dyspnea will be measured using the mutlidimensionnal dyspnea profile questionnaire (MDP), graded on a 10-point scale
Measured: During visit 2-3-4, from start to end of the endurance exercise test at every 90-sec intervals, up to 20 minutes. Participants will be followed for an expected period of 3 weeks (from date of randomization to the completion of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Maltais, Francois, M.D., Saey, Didier, M.D., Dr Louis Laviolette, Dr Thomas Similowski
- Responsible party
- Principal investigator, Philippe Gagnon, PhD Candidate, Laval University
- Investigators
- François Maltais, MD, Principal investigator, Centre de recherche - Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902927
- Sponsor's protocol ID
- DVD-20948
- Acronym
- DVD
- Status last verified
- Jul 2013
- First submitted
- 10 Jul 2013
- Last updated
- 18 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Dyspnea Perception During Exercise in COPD Patients Using Attentional Distraction : a Pilot Study
- ClinicalTrials.gov ID
- NCT01902927
- Acronym / sponsor ID
- DVD / DVD-20948
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Exercise tolerance, Dyspnea, Affective distraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Maltais, Francois, M.D., Saey, Didier, M.D., Dr Louis Laviolette, Dr Thomas Similowski
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 18 Jul 2013 (estimated)
- 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.
Chronic obstructive pulmonary disease (COPD) is a major health problem whose prevalence is increasing rapidly. The gradual decrease in exercise tolerance is one of the usual consequences of COPD that affects the functional independence and quality of life of patients.
In COPD patients, breathlessness and muscle fatigue are the main symptoms limiting exercise. Recent studies have shown that most of the physiological mechanisms of psychological factors such as emotions, motivation, memory, personality, expectations, or prior experience can greatly influence and modulate the perception of breathlessness. It has been proposed that the attentional distraction (visual or auditory) during exercise may be associated with a decrease in anxiety and shortness of breath and could improve exercise tolerance in COPD. We therefore propose to study the impact of attentional strategies of distraction on the perception of dyspnea and walking tolerance in patients with COPD.
The research hypotheses are:
- Compared with exposure to a strategy of negative attentional distraction during exercise, exposure to a strategy of positive attentional distraction will improve walking exercise tolerance in patients with COPD; ii) For a given level of effort, sensory perception and emotional perception will be enhanced by exposure to a strategy of positive attentional distraction.
Ten subjects with moderate to severe COPD will be recruited at the Research Center of the Institut Universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ). During an assessment visit, we will measure complete pulmonary function, body composition and maximal functional capacity during a maximal incremental test work performed on a treadmill.
During two subsequent experimental visits, and after spirometry control, participants will perform a walking test performed on a treadmill at an intensity corresponding to 75% of maximum effort during maximal incremental test. The test will be carried out in combination with a strategy of either positive attentional distraction, neutral attentional distraction or negative attentional distraction . The order of the condition will be randomized.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | Experimental | Other: Attentional distraction using IAPS protocol (standardized images)COPD patients will perform a constant workrate treadmill exercise test until exhaustion with positve/neutral/negative visual distraction images during the exercise test assigned in a randomized order |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Smoking history > 10 pack-years
- Post-BD FEV1 [30-80 % predicted value]
- Post-BD FEV1/FVC < 70 %
- Age [50-80 yrs]
- Voorips score < 9
Key exclusion criteria (7 listed)
- Exacerbation < 4 weeks
- Asthma, Neoplasia, Cardiac failure, Diabetes
- Neuromuscular limitations
- Major depression or other psychiatric disorders
- BMI > 30 kg/m2
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 |
|---|---|---|
| Attentional distraction using IAPS protocol (standardized images)Positive, Negative and Neutral Attentional distraction will be presented using IAPS protocol (standardized images) during exercise tests | Other | COPD patients |
Primary outcome
Exercise tolerance
Time frame: During each experimental visit (V2-V3-V4), from the start to the end of the exercise test (limited by symptoms of the patients). Participants will be followed for an expected period of 3 weeks (from date of randomization to the completion of the study)
The exercise tolerance (sec) will be defined as the time to exhaustion following a standardized constant workrate treadmill walking test corresponding to 75 % of maximal workload previously determined.
2 secondary outcomes
Dyspnea perception
Time frame: During visit 2-3-4, from start to end of the endurance exercise test at every 90-sec intervals, up to 20 minutes. Participants will be followed for an expected period of 3 weeks (from date of randomization to the completion of the study)
Dyspnea affective perception
Time frame: During visit 2-3-4, from start to end of the endurance exercise test at every 90-sec intervals, up to 20 minutes. Participants will be followed for an expected period of 3 weeks (from date of randomization to the completion of the study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2013.
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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.
François Maltais, MD principal investigator
Centre de recherche - Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attentional distraction using IAPS protocol (standardized images) in people with Chronic Obstructive Pulmonary Disease, run by Laval University at 1 site in Canada.
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 5 inclusion and 7 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 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Philippe Gagnon, PhD (418-656-8711 ext. 2672, philippe.gagnon.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise tolerance (time frame: During each experimental visit (V2-V3-V4), from the start to the end of the exercise test (limited by symptoms of the patients). Participants will be followed for an expected period of 3 weeks (from date of randomization to the completion of the study)). 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 18 Jul 2013.