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

NCT01902927 | Unknown

• 1 other identifier: DVD-20948
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Exercise tolerance; Dyspnea; Affective distraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dyspnea perception

  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

  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)

Study Arms (1)

COPD patients

EXPERIMENTAL

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)

Interventions

Attentional distraction using IAPS protocol (standardized images) OTHER

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

COPD patients

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Maltais, Francois, M.D.: collaborator
• Saey, Didier, M.D.: collaborator
• Dr Louis Laviolette: collaborator
• Dr Thomas Similowski: collaborator

Study Sites (1)

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

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• François Maltais, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Gagnon, PhD

CONTACT

418-656-8711; philippe.gagnon.1@ulaval.ca

Didier Saey, PhD

CONTACT

418-656-8711; didier.saey@rea.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 18, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

CA (1)