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

Chronic Obstructive Pulmonary Disease Clinical Trial

— DVD  

Official title:

Modulation of Dyspnea Perception During Exercise in COPD Patients Using Attentional Distraction : a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01902927
• Other study ID #: DVD-20948
• Status: Not yet recruiting
• Phase: N/A
• First received: July 10, 2013
• Last updated: July 16, 2013
• Start date: July 2013
• Est. completion date: October 2013

Study information

• Verified date: July 2013
• Source: Laval University
• Contact: Philippe Gagnon, PhD
• Phone: 418-656-8711
• Email: philippe.gagnon.1[@]ulaval.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Québec	Quebec

Sponsors (5)

Lead Sponsor	Collaborator
Laval University	Dr Didier Saey, Dr François Maltais, Dr Louis Laviolette, Dr Thomas Similowski

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)	No
Secondary	Dyspnea perception	The dyspnea intensity will be measured using a 10-point Borg scale during the exercise test	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)	No
Secondary	Dyspnea affective perception	The affective perception of dyspnea will be measured using the mutlidimensionnal dyspnea profile questionnaire (MDP), graded on a 10-point scale	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)	No