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

NCT ID: NCT01902927

Last Updated: 2013-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Attentional distraction using IAPS protocol (standardized images)

Intervention Type OTHER

Positive, Negative and Neutral Attentional distraction will be presented using IAPS protocol (standardized images) during exercise tests

Interventions

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Attentional distraction using IAPS protocol (standardized images)

Positive, Negative and Neutral Attentional distraction will be presented using IAPS protocol (standardized images) during exercise tests

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maltais, Francois, M.D.

INDUSTRY

Sponsor Role collaborator

Saey, Didier, M.D.

INDIV

Sponsor Role collaborator

Dr Louis Laviolette

UNKNOWN

Sponsor Role collaborator

Dr Thomas Similowski

UNKNOWN

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Philippe Gagnon, PhD Candidate

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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François Maltais, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche - Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

Locations

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Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, Quebec, Canada

Site Status

Countries

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Canada

Central Contacts

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Philippe Gagnon, PhD

Role: CONTACT

418-656-8711 ext. 2672

Didier Saey, PhD

Role: CONTACT

418-656-8711 ext. 2614

Facility Contacts

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Philippe Gagnon, PhD

Role: primary

418-656-8711 ext. 2672

Didier Saey, PhD

Role: backup

418-656-8711 ext. 2614

Other Identifiers

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DVD-20948

Identifier Type: -

Identifier Source: org_study_id

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