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临床试验/NCT01902927
NCT01902927Unknown不适用

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

Laval University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Exercise tolerance

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Exercise tolerance

时间窗: 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.

次要结局

  • 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))
  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Philippe Gagnon, PhD Candidate

PhD

Laval University

研究点 (2)

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