Ignite Creation Date:
2024-05-05 @ 11:35 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01360788
Status:
COMPLETED
Last Update Posted:
2011-05-26
First Post:
2011-05-12
Brief Title:
GOLD Stage I Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Laval University
Organization:
Laval University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GOLD
Brief Summary:
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 07 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 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None