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Modulation of Dyspnea Perception During Exercise in COPD Patients Using Attentional Distraction (DVD)

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ClinicalTrials.gov Identifier: NCT01902927
Recruitment Status : Unknown
Verified July 2013 by Philippe Gagnon, PhD Candidate, Laval University.
Recruitment status was:  Not yet recruiting
First Posted : July 18, 2013
Last Update Posted : July 18, 2013
Sponsor:
Collaborators:
Maltais, Francois, M.D.
Saey, Didier, M.D.
Dr Louis Laviolette
Dr Thomas Similowski
Information provided by (Responsible Party):
Philippe Gagnon, PhD Candidate, Laval University

Brief 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.

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:

i) 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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Attentional distraction using IAPS protocol (standardized images) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Modulation of Dyspnea Perception During Exercise in COPD Patients Using Attentional Distraction : a Pilot Study
Study Start Date : July 2013
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COPD patients
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
Other: Attentional distraction using IAPS protocol (standardized images)
Positive, Negative and Neutral Attentional distraction will be presented using IAPS protocol (standardized images) during exercise tests




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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) ]
    The dyspnea intensity will be measured using a 10-point Borg scale during the exercise test

  2. 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) ]
    The affective perception of dyspnea will be measured using the mutlidimensionnal dyspnea profile questionnaire (MDP), graded on a 10-point scale



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smoking history > 10 pack-years
  • Post-BD FEV1 [30-80 % predicted value]
  • Post-BD FEV1/FVC < 70 %
  • Age [50-80 yrs]
  • Voorips score < 9

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902927


Contacts
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Contact: Philippe Gagnon, PhD 418-656-8711 ext 2672 philippe.gagnon.1@ulaval.ca
Contact: Didier Saey, PhD 418-656-8711 ext 2614 didier.saey@rea.ulaval.ca

Locations
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Canada, Quebec
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) Not yet recruiting
Québec, Quebec, Canada, G1V 4G5
Contact: Philippe Gagnon, PhD    418-656-8711 ext 2672    philippe.gagnon.1@ulaval.ca   
Contact: Didier Saey, PhD    418-656-8711 ext 2614    dider.saey@rea.ulaval.ca   
Principal Investigator: François Maltais, MD         
Sponsors and Collaborators
Laval University
Maltais, Francois, M.D.
Saey, Didier, M.D.
Dr Louis Laviolette
Dr Thomas Similowski
Investigators
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Principal Investigator: François Maltais, MD Centre de recherche - Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

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Responsible Party: Philippe Gagnon, PhD Candidate, PhD, Laval University
ClinicalTrials.gov Identifier: NCT01902927     History of Changes
Other Study ID Numbers: DVD-20948
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013

Keywords provided by Philippe Gagnon, PhD Candidate, Laval University:
Exercise tolerance
Dyspnea
Affective distraction

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Dyspnea
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms