Physical Activity Clinical Trial
Official title:
GOLD Stage I COPD: Is it Really a Disease ? Exercise Tolerance, Muscle Function and Response to Bronchodilation in GOLD Stage I COPD Patients
Recently integrated in clinical practice, the Global Initiative for Chronic Obstructive Lung
Disease (GOLD) classification states that a mild (stage I) chronic obstructive pulmonary
disease (COPD) is present, in a smoker, when the postbronchodilator forced expired volume in
1 second (FEV1) to forced vital capacity (FVC) ratio is < 0.7. A major change that was
introduced by the GOLD classification system was that COPD could be diagnosed despite an
FEV1 that is within normal predicted values (above 80% predicted). Because it suggests
diagnosing and detecting COPD earlier than done until very recently in medical practice, the
GOLD standards bring in a new reality to clinicians. In fact, this novel COPD classification
comes with new research challenges because the functional impacts and systemic consequences
related to COPD are mostly documented in patients with moderate to severe stages with little
information specifically in GOLD stage I COPD. This information is important if the
investigators are to convince physicians that GOLD stage I COPD needs to be diagnosed and
eventually treated.
The investigators aimed to characterize GOLD stage I COPD patients according to
activity-related dyspnea. More specifically, our objectives were to compare:
i) baseline pulmonary function ii) exercise capacity iii) quadriceps muscle function iv)
levels of physical activity in daily life
between symptomatic (Sx) GOLD stage I COPD patients, asymptomatic (ASx) GOLD stage I COPD
patients and healthy control subjects (CTRL). The investigators reasoned that exercise
tolerance and physical activity levels would be decreased in Sx GOLD stage I COPD patients
as it would be similar between ASx GOLD stage I COPD patients and CTRL.
The study will be conducted among three subgroups: symptomatic GOLD stage I patients with
COPD, asymptomatic patients GOLD stage I COPD and healthy control subjects with normal lung
function. Subjects will be paired for age, sex and smoking history. The project will require
three visits. In the initial visit, assessment of the pulmonary function with respiratory
symptoms quantification will allow to classify subjects in the proper subgroup. The Medical
Research Council (MRC) dyspnea scale will serve as the reference outcome to determine
whether COPD patients are symptomatic or not. Patients with an MRC dyspnea score < 2 will be
considered asymptomatic. A second questionnaire (ATS-DLD-78) will serve to document cough,
expectorations, wheezing and smoking history in every subjects. Body composition will be
measured by bioimpedance and by waist circumference after a blood sample taken in the
morning, in a fasting state. A six-minute walk test (6MWT) will be performed by all
subjects. After a one-hour resting period, a maximal incremental shuttle walking test will
be realized in the same visit to quantify maximal exercise capacity. Measures of force and
endurance of the quadriceps will be taken by magnetic stimulation of the femoral nerve
before the maximal walking test. Finally, subjects will receive a portable device to monitor
physical activity for a period of 7 days.
In the 2nd and 3rd visits, subjects will realize an endurance walking test at 85 % of their
predetermined maximal capacity. Before each endurance test, a bronchodilator or a placebo
will be administered following a randomized double-blind design. Measures of force and
endurance of the quadriceps will be taken by magnetic stimulation of the femoral nerve
before and 10-min after endurance exercise tests. A needle biopsy of the vastus lateralis
will be performed at the end of the third visit.
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Observational Model: Case Control, Time Perspective: Cross-Sectional
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