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

Sponsor
Laval University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01902927
Collaborator
Maltais, Francois, M.D. (Industry), Saey, Didier, M.D. (Other), Dr Louis Laviolette (Other), Dr Thomas Similowski (Other)
10
1
1
3
3.3

Study Details

Study Description

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:
  1. 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;

  2. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Attentional distraction using IAPS protocol (standardized images)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title:
Modulation of Dyspnea Perception During Exercise in COPD Patients Using Attentional Distraction : a Pilot Study
Study Start Date :
Jul 1, 2013
Anticipated Primary Completion Date :
Oct 1, 2013
Anticipated Study Completion Date :
Oct 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Exercise tolerance [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)]

    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.

Secondary Outcome Measures

  1. 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)]

    The dyspnea intensity will be measured using a 10-point Borg scale during the exercise test

  2. 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)]

    The affective perception of dyspnea will be measured using the mutlidimensionnal dyspnea profile questionnaire (MDP), graded on a 10-point scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) Québec Quebec Canada G1V 4G5

Sponsors and Collaborators

  • Laval University
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Philippe Gagnon, PhD Candidate, PhD, Laval University
ClinicalTrials.gov Identifier:
NCT01902927
Other Study ID Numbers:
  • DVD-20948
First Posted:
Jul 18, 2013
Last Update Posted:
Jul 18, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Philippe Gagnon, PhD Candidate, PhD, Laval University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2013