Clinical trial NCT01902927: Modulation of Dyspnea Perception During Exercise in COPD Patients Using Attentional Distraction
Official title: Modulation of Dyspnea Perception During Exercise in COPD Patients Using Attentional Distraction : a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Exercise tolerance
Dyspnea
Affective distraction
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Maltais, Francois, M.D.
name: Saey, Didier, M.D.
name: Dr Louis Laviolette
name: Dr Thomas Similowski
First posted: 2013-07-18
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: Exercise tolerance
timeFrame: 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:
measure: Dyspnea perception
timeFrame: 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)
measure: Dyspnea affective perception
timeFrame: 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)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
state: Quebec
Study officials:
affiliation: Centre de recherche - Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
name: François Maltais, MD
role: PRINCIPAL_INVESTIGATOR
References: