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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Attentional distraction using IAPS protocol (standardized images)

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Gagnon, PhD; Phone Number: 2672 418-656-8711; Email: philippe.gagnon.1@ulaval.ca
• Study Contact Backup: Name: Didier Saey, PhD; Phone Number: 2614 418-656-8711; Email: didier.saey@rea.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
      • Contact: Philippe Gagnon, PhD; Phone Number: 2672 418-656-8711; Email: philippe.gagnon.1@ulaval.ca
      • Contact: Didier Saey, PhD; Phone Number: 2614 418-656-8711; Email: dider.saey@rea.ulaval.ca
      • Principal Investigator: François Maltais, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Maltais, Francois, M.D.; Saey, Didier, M.D.; Dr Louis Laviolette; Dr Thomas Similowski
• Investigators: Principal Investigator: François Maltais, MD, Centre de recherche - Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): October 1, 2013

Study Registration Dates

• First Submitted: July 10, 2013
• First Submitted That Met QC Criteria: July 16, 2013
• First Posted (Estimate): July 18, 2013

Study Record Updates

• Last Update Posted (Estimate): July 18, 2013
• Last Update Submitted That Met QC Criteria: July 16, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Dyspnea; Exercise tolerance; Affective distraction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
• Other Study ID Numbers: DVD-20948